Langer-Giedion Syndrome

Study presents new persistence analysis of FINTEPLA, evaluating the efficacy and tolerability of FINTEPLA over a span of 12 months1 Real-world data looks into the need for resources to support caregivers – both parents and siblings – of people living with developmental and epileptic encephalopathies such as Dravet and Lennox-Gastaut syndromes in the transition from pediatric to long-term adult care2 Systematic literature review underscores the need for more impactful conversations between patients, caregivers and clinicians about sudden unexpected death in epilepsy (SUDEP)3 These research and findings demonstrate UCB's commitment to symptom management as well as holistic patient care ATLANTA, Dec. 2, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced data being presented at the American Epilepsy Society (AES) Annual Meeting, taking place December 1–5 in Orlando, Florida, that focus on the real-world experiences of people living with rare epilepsy syndromes and their caregivers, in addition to several other presentations of clinical data evaluating the efficacy, safety and tolerability of FINTEPLA as a treatment for seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Continue Reading Fintepla® (fenfluramine) 2.2 mg/mL oral solution) People living with a severe group of rare epilepsies called developmental and epileptic encephalopathies (DEEs), including DS and LGS, experience frequent and prolonged seizures, significant behavioral and developmental delays, movement and balance issues, and sleep difficulties.4 These ongoing challenges can create significant obstacles for both patients and their caregivers, as the conditions often require consistent and lifelong management to mitigate the dangerous side effects and detrimental impacts on quality of life.5 "It is critical to address not only seizures but also the non-seizure outcomes that can severely impact overall quality of life for people living with rare epilepsies and their caregivers," said Brad Chapman, Head of U.S. Epilepsy and Rare Syndromes at UCB. "The robust data being presented at AES reflect UCB's commitment to research and resources that support the rare epilepsy community. By continuing to deepen our understanding of the real-world experiences faced by people living with rare epilepsy syndromes (acute repetitive seizures and focal epilepsy), we will be able to better support their journey to finding appropriate treatment options faster and provide resources and education over the long term." The real-world evidence being presented at AES supports the need to integrate the lived experiences of the rare epilepsy community into the development of treatment options and resources, to bring more holistic care to people living with rare epilepsies and their caregivers. "Providing proactive education and counseling for people living with rare epilepsy syndromes and their caregivers is critical for improving seizure control, appropriate treatment adherence and management of risks like SUDEP," said Tom Stanton, President of the Danny Did Foundation and study investigator. "To achieve effective communication, neurologists need support to help them initiate difficult discussions about potentially negative impacts on quality of life. With the proper tools, providers can play a big role to empower and inform patients and caregivers." The real-world data on fenfluramine, long-term care planning for rare epilepsy syndrome patients, and SUDEP counselling being presented at AES include: A 12-Month Persistence Analysis of Fenfluramine, Valproate, and Levetiracetam in Individuals with Dravet Syndrome: A Comparison Using U.S. Claims Data1 A new analysis utilizing U.S. real-world data of fenfluramine in people living with DS.1 Data from this late-breaking poster presentation featured U.S. healthcare claims data from Komodo Healthcare showing the persistency of fenfluramine – defined as the duration of continuous treatment without a gap of more than 90 days.1 A Survey of Rare Epilepsy Parents and Adult Siblings: To Assess Resources Needed to Prepare Families Living in the U.S. for Long-term Adult Care Planning for Their Loved One2 Survey assessed resources and needs required for caregivers' long-term care planning for a family member diagnosed with a developmental and epileptic encephalopathy (DEE). 2 Data from a survey of 135 caregivers of people with rare epilepsy syndromes, including parents and adult siblings, found that only 22% believed they had adequate access to long-term care planning information, while 53% did not have information available to them, and 24% were unsure. Those surveyed cited frustration in finding support and resources for patients with rare epilepsy syndromes and concern about how patients and their caregivers will be supported as they transition into adulthood.2 No family support programs or resources currently exist for long-term adult care planning or for the transfer of primary care for those living with rare epilepsy syndromes, uncovering a significant unmet need for additional support to facilitate future medical, legal and financial planning and ensure caregivers have access to resources and support at every step of their care journey.2 Bridging The Gap Between Neurologists and People with Epilepsy/Caregivers: Systematic Literature R eview about SUDEP Conversations3 Research looks to understand and learn more about caregivers' needs and experiences and neurologists' attitudes and behaviors toward SUDEP conversations. 3 A critical element of care for people living with epilepsy and rare epilepsy syndromes is the continuous management of risk related to sudden unexpected death in epilepsy (SUDEP), a leading disease-related cause of mortality among people living with epilepsy, affecting approximately one in 1,000 adults with epilepsy yearly6 and one in 150 for those with inadequate seizure control.7 A systematic literature review of studies found a gap between what people living with epilepsy and their caregivers want regarding information about SUDEP and the information shared with them by their neurologists.3 While many neurologists reported not actively discussing SUDEP to avoid causing fear or negative emotions, data show that patients and caregivers want to have more proactive discussions about SUDEP to provide them with the opportunity to take preventive measures. Increasing education for people with epilepsy and their caregivers about SUDEP, as well as providing neurologists with support and training to become adept at initiating these difficult discussions, are critical to help build a trusting partnership to enhance epilepsy management and, in turn, reduce the risks of SUDEP.3 In addition to the other accepted posters at AES, UCB will present additional clinical data on FINTEPLA. Click here to learn more. About Epilepsy Epilepsy is a common neurological condition worldwide and affects approximately 50 million people.8 Epilepsy and seizures can develop in any person at any age9 and is usually diagnosed after a person has had at least two seizures (or after one seizure with a high risk for more) that were not caused by some known medical condition.10 About UCB in Epilepsy For three decades, we've been committed to people living with epilepsy and their families, surrounding the patient and caregiver through every step of their care journey. At our core, we have a responsibility to elevate the healthcare ecosystem. Because of this, we have established our legitimacy on the front lines of epilepsy research, development, and treatment innovation. But our past breakthroughs are only a prologue to our future. We will continue to reimagine how we care for patients, leveraging today's expertise for a better tomorrow. With so much experience behind us and so much potential ahead, we are more invested than ever in profoundly improving the lives of those living with or caring for those with epilepsy or a rare epilepsy syndrome – through our relentless pursuit of a seizure-free life. About FINTEPLA® (fenfluramine) Oral Solution 11 FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS. Further information is available at or by telephone at +1 877 964 3649. IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. FINTEPLA is available only through a restricted program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): Because of the association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors. Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg. USE IN SPECIFIC POPULATIONS In patients with severe impairment of kidney function (estimated glomerular filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are recommended. FINTEPLA has not been studied in patients with kidney failure (eGFR <15 mL/min/1.73m2). Combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (Child-Pugh Class A, B, and C), necessitating a dosage adjustment in these patients. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1‑844-599-2273 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information , including Boxed Warning and Medication Guide , for additional Important Safety Information on FINTEPLA. For further information, contact UCB: Corporate Communications Becky Malone, U.S. Media Relations T +919.605.9600 [email protected] Investor Relations Antje Witte T +32.2.559.9414 [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of € 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. References Jaganathan S, et al. A 12-month persistence analysis of fenfluramine, valproate, and levetiracetam in individuals with Dravet Syndrome: a comparison using US claims data. Poster presented at American Epilepsy Society Annual Meeting; December 1-5, 2023; Orlando, Florida. Laurie D Bailey, et al. A Survey of Rare Epilepsy Parents and Adult Siblings: To Assess Resources Needed to Prepare Families Living in the U.S. for Long-term Adult Care Planning for Their Loved. Abstract presented at American Epilepsy Society Annual Meeting; December 1-5, 2023; Orlando, Florida. Luker J, et al. Bridging the gap between neurologists and people with epilepsy/caregivers: systematic literature review about SUDEP conversations. Poster presented at American Epilepsy Society Annual Meeting; December 1-5, 2023; Orlando, Florida. Epilepsy Foundation. Developmental and Epileptic Encephalopathy (DEE). Available at: . Accessed November 2023. Salom R, Aras LM, Piñero J, Duñabeitia JA. The psychosocial impact of caring for children with Dravet Syndrome. Epilepsy Behav Rep. 2023;24:100619. Harden C, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88:1674-1680. Child Neurology Foundation. SUDEP. Available at: . Accessed November 2023. Meyer AC, Dua T, Ma J, et al. Global disparities in the epilepsy treatment gap: a systemic review. Bull World Health Organ. 2010;88: 260-266. Epilepsy Foundation. Who Can Get Epilepsy? Available at: . Accessed November 2023. Epilepsy Foundation: What is Epilepsy? Available at: . Accessed November 2023. FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc. FINTEPLA® is a registered trademark of the UCB Group of Companies. ©2023 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-FA-2300166 SOURCE UCB

UCB will present 29 abstracts, including 4 late breakers, at American Epilepsy Society Annual Meeting 2023 highlighting clinical, health economic and demographic studies in epilepsy Presentations showcase diversity, potential and momentum of UCB's epilepsy and rare syndromes portfolio, including important fenfluramine and brivaracetam data Broad data sets reveal insights into different epilepsy types and different populations living with epilepsies Molecular, clinical, and real-world research focuses on current and future patient needs in epilepsy ATLANTA, Dec. 1, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today unveiled its extensive program of 29 studies, including 4 late breakers, accepted for presentation at the AES Annual Meeting 2023, taking place from 1-5 December in Orlando, Florida. "The data being presented at this year's American Epilepsy Society meeting highlight UCB's commitment to transforming outcomes and experiences for people living with epilepsies, redefining the future of epilepsy care. We are proud of the innovation and impact we have been able to deliver over the past three decades with our evolving portfolio of innovative medicines, and look forward to continuing to partner with patients, carers, and the scientific community to address unmet needs and advance the next generation of epilepsy care," said Mike Davis, Global Head of Epilepsy & Rare Syndromes, UCB. Key scientific and patient-focused data include: In focal-onset seizures (FOS) - interim data from a post-marketing non-interventional study on effectiveness and quality of life (QoL) with adjunctive brivaracetam in earlier treatment lines. In Dravet syndrome - an analysis from an open-label extension study of adults treated with fenfluramine. In Lennox-Gastaut syndrome - a post hoc analysis evaluating the percentage of seizure-free days in patients treated with fenfluramine in the 14-week randomized control trial and its open-label extension (median treatment duration, 1 year). In prolonged seizures - three studies evaluating the safety, tolerability, and pharmacokinetics of single-use inhaled alprazolam (an investigational treatment for potential termination of prolonged epileptic seizures) in different populations. In SUDEP (Sudden Unexpected Death in Epilepsy) - a literature review highlighting the differences in provision of information between healthcare professionals and patients. In disease management - data from early research into mechanisms underlying Developmental and Epileptic Encephalopathies (DEE). In health equity - results from a survey of US neurologists on health disparities in black patients living with epilepsy. "Knowledge illuminates a path toward innovative solutions and transformative breakthroughs. At this year's American Epilepsy Society meeting, we converge not just as researchers and clinicians, but as pioneers of progress. For three decades, we've been committed to people living with epilepsy and their families. We aim for a future where every discovery moves us closer to a seizure-free life. In unity, we work to surround the patient and caregiver through every step of their care journey – from diagnosis to treatment to support in helping them navigate those moments in their lives that matter most," said Brad Chapman, Head of U.S. Epilepsy and Rare Syndromes. Symposia and CME UCB will be hosting a symposium on December 2 at 6:00 p.m. ET entitled "The 'window of opportunity': Recognizing the importance of rapid and early seizure termination", to shed further light on seizure emergencies and data being presented at AES on the Seizure Termination Project*. The project consists of an expert consensus group sharing best practice for rapid and early seizure termination (REST) to prevent progression to a higher-level emergency. UCB is also supporting a CME program entitled 'Beyond Seizures: The Evolving Standard of Care in Developmental and Epileptic Encephalopathies' taking place on 1 December. UCB data presentations at AES 2023 Saturday, December 2, 2023 (12:00 PM –2:00 PM ET) Sunday, December 3, 2023 (12:00 PM –2:00 PM ET) *The Seizure Termination Project was funded by UCB Pharma. **The safety and efficacy of STACCATO® alprazolam has not been established and it is not currently approved for use in this indication by any regulatory authority worldwide. Monday, December 4, 2023 (12:00 PM –1:45 PM ET) For further information, contact UCB: Corporate Communications Becky Malone, U.S. Media Relations T +919.605.9600 Email [email protected] Investor Relations Antje Witte T +32.2.559.94.14 Email [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. Important Safety Information about FINTEPLA® (fenfluramine) in the US1 FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS. Further information is available at or by telephone at +1 877 964 3649. IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. FINTEPLA is available only through a restricted program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): Because of the association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors. Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg. USE IN SPECIFIC POPULATIONS In patients with severe impairment of kidney function (estimated glomerular filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are recommended. FINTEPLA has not been studied in patients with kidney failure (eGFR <15 mL/min/1.73m2). Combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (Child-Pugh Class A, B, and C), necessitating a dosage adjustment in these patients. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1‑844-599-2273 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information , including Boxed Warning and Medication Guide , for additional Important Safety Information on FINTEPLA. Important Safety Information about BRIVIACT® (brivaracetam) in the US2 BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. WARNINGS AND PRECAUTIONS Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider. Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT. Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms in adult and pediatric patients. Advise patients to report these symptoms immediately to a healthcare provider. Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients. Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. DOSING CONSIDERATIONS Dose adjustments are recommended for patients with all stages of hepatic impairment. When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended. ADVERSE REACTIONS In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those in adult patients. Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain. BRIVIACT is a Schedule V controlled substance. Please refer to the full Prescribing Information and visit . Important Safety Information about VIMPAT® (lacosamide) in the US3 VIMPAT® is indicated for treatment of partial-onset seizures in patients 1 month of age and older, and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. VIMPAT IMPORTANT SAFETY INFORMATION VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity. Partial-Onset Seizures In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%). Primary Generalized Tonic-Clonic Seizures In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizures trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea. Pediatric Patients Adverse reactions reported in clinical studies for partial-onset seizures in patients 1 month to less than 17 years of age and for primary generalized tonic-clonic seizures for patients 4 to less than 17 years of age were similar to those seen in adult patients. Injection In adult adjunctive therapy clinical trials for partial-onset seizures, adverse reactions with intravenous administration generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). When administering a loading dose, the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia, may be higher with 15-minute administration than over a 30- to 60-minute period. The adverse reactions associated with VIMPAT injection in adult patients with primary generalized tonic-clonic seizures are expected to be similar to those seen in adults with partial- onset seizures. The adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults. Infusion times less than 30 minutes were not adequately studied in pediatric patients. VIMPAT (lacosamide) is a Schedule V controlled substance. Please refer to the full Prescribing Information. ­­­­References: Fintepla® US PI. FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc. BRIVIACT (brivaracetam) prescribing information. Smyrna, GA: UCB, Inc. VIMPAT (lacosamide): US prescribing information. Smyrna, GA: UCB, Inc. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. 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Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. BRIVIACT®, FINTEPLA®, and UCBCares® are registered trademarks of the UCB Group of Companies. VIMPAT® is a registered trademark used under license from Harris FRC Corporation. Staccato® is a registered trademark of Alexza Pharmaceuticals, Inc., and is used by UCB Pharma under license. ©2023 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-BR-2300119 SOURCE UCB

Data from nine abstracts to be presented, including real-world outcomes of Epidiolex® (cannabidiol) in treatment-resistant focal epilepsies Presentations include data on U.S. caregiver-reported seizure and non-seizure outcomes in patients with tuberous sclerosis complex prescribed Epidiolex DUBLIN, Dec. 1, 2023 /PRNewswire/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that nine company-sponsored presentations, including five late-breaking abstracts, will be shared at the 2023 American Epilepsy Society (AES) annual meeting, being held December 1-5 in Orlando, Florida. Late-breaking presentations include a post-hoc analysis examining real-world outcomes of Epidiolex® (cannabidiol) in treatment-resistant focal epilepsies within the Expanded Access Program (EAP), as well as a post-hoc analysis of the GWPCARE6 Open-Label Extension (OLE) trial evaluating the effectiveness of Epidiolex as add-on therapy against focal seizures in tuberous sclerosis complex (TSC). Two additional late-breaking abstracts will feature interim results from the BECOME-TSC (BEhavior, COgnition, and More with Epidiolex) Survey of caregivers of patients with TSC. These abstracts will report seizure and non-seizure outcomes with real-world use of Epidiolex in TSC and further expand the results of the original BECOME survey conducted among caregivers of people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) that were presented at the 2022 AES meeting. "Multiple presentations at the 2023 AES meeting continue to build the scientific evidence in support of Epidiolex and improve understanding around the treatment's full impact," said Kelvin Tan, MBBCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals. "In addition to seizure outcomes, the BECOME studies are also designed to assess non-seizure benefits of Epidiolex, such as cognition and executive function, emotional and social function, and language and communication. We are determined to not only address seizure outcomes for patients living with rare epilepsies, but also improve the day-to-day lives for both patients and their loved ones." Data highlights at the 2023 AES annual meeting include: A post-hoc analysis of patients diagnosed with treatment-resistant focal epilepsy within the EAP that demonstrated Epidiolex was associated with a sustained reduction in focal-onset seizures through 144 weeks. Notably, a second post-hoc analysis investigated the effectiveness and safety results of Epidiolex in adult patients from the EAP which found similar outcomes among patients with treatment-resistant epilepsies, including focal seizures. The EAP was an initiative launched in 2014 to provide add-on Epidiolex to patients with treatment-resistant epilepsy at 35 U.S. epilepsy centers. A post-hoc analysis of the GWPCARE6 OLE trial evaluating the effectiveness of Epidiolex as add-on therapy against focal seizures in TSC. At least 50% reduction was reported by the majority of patients across focal seizure types through 144 weeks. Additionally, responder rates for focal seizure subtypes were consistent with the overall focal seizure responder rates, and the safety pro in the analysis was consistent with that observed in its overall clinical development program. Interim results of the BECOME-TSC survey, in which the majority of caregivers reported patient improvements in overall seizure frequency and severity, as well as improvements in patients' cognition, emotional functioning, and communication domains. The 2023 AES abstracts are available online at the following link: . A full list of Jazz Pharmaceuticals' presentations follows below: About Tuberous Sclerosis Complex Tuberous sclerosis complex (TSC) is a rare genetic condition.1 The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs2 and is a leading cause of genetic epilepsy.3 People with TSC may experience a variety of seizure types. One of the most common is infantile spasms that typically present in the first year of life; focal (or partial) seizures are also very common.4 TSC is associated with an increased risk of autism and intellectual disability5 and the severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.4 Epilepsy is present in about 85 percent of patients with TSC and may progress to become intractable to medication.4,6,7 More than 60 percent of individuals with TSC do not achieve seizure control8 with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation8 compared to 30-40 percent of individuals with epilepsy who do not have TSC who are drug resistant.9,10 About Dravet Syndrome Dravet syndrome (DS) is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms).11 Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with DS typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others. About Lennox-Gastaut Syndrome Lennox-Gastaut syndrome (LGS) begins in childhood. It is characterized by multiple types of seizures. People with LGS begin having frequent seizures in early childhood, usually between ages 3 and 5.12 More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with LGS develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with LGS require help with usual activities of daily living. About Epidiolex®/Epidyolex® (cannabidiol) EPIDIOLEX/EPIDYOLEX is a prescription, plant-derived cannabis-based medicine administered as an oral solution which contains highly purified cannabidiol (CBD). Cannabidiol, the active ingredient in EPIDIOLEX, is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. The precise mechanisms by which EPIDIOLEX exerts its anticonvulsant effect in humans are unknown. Epidiolex, approved by the U.S. Food and Drug Administration (FDA) for use in the U.S., the European Commission (EC) for use in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain, the Therapeutic Goods Administration for use in Australia, Swissmedic for use in Switzerland, and the Food & Nutrition Services of the Israel Ministry of Health for use in Israel, is an oral solution which contains highly purified cannabidiol. In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex received Orphan Drug Designation from the U.S. FDA for the treatment of seizures associated with LGS, DS and TSC. Epidiolex has received approval in the European Union under the tradename Epidyolex for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older. Epidyolex has received Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of seizures associated LGS, DS and TSC. A Phase 3 study is ongoing in Japan evaluating cannabidiol in patients with LGS, DS and TSC. Important Safety Information & Indications CONTRAINDICATION: HYPERSENSITIVITY EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product. WARNINGS & PRECAUTIONS Hepatocellular Injury: EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Transaminase and bilirubin levels should be obtained prior to starting treatment, at one, three, and six months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. Somnolence and Sedation: EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness. Withdrawal of Antiepileptic Drugs: As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. Adverse Reactions: The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed. Pregnancy: EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Drug Interactions: Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary. Indications: EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. Please refer to the EPIDIOLEX full Prescribing Information for additional important information here. About Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. Please visit for more information. Investors: Andrea N. Flynn, Ph.D. Vice President, Head, Investor Relations Jazz Pharmaceuticals plc InvestorInfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717 References 1 TS Alliance. What is TSC? . Accessed November 2023. 2 National Institute of Neurological Disorders and Stroke. Tuberous Sclerosis Complex. . Accessed November 2023. 3 TS Alliance. What is tuberous sclerosis complex? . Accessed November 2023. 4 Kingswood JC, d'Augères GB, Belousova E, et al. TuberOus SClerosis registry to increase disease Awareness (TOSCA) - baseline data on 2093 patients. 2017;12(1):2. 5 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157. 6 Tuberous Sclerosis Alliance. Diagnosis, Surveillance and Management for Healthcare Professionals. . Accessed October 2023. 7 Jeong A, Wong M. Systemic disease manifestations associated with epilepsy in tuberous sclerosis complex. Epilepsia. 2016;57(9):1443-1449. 8 Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA. The natural history of epilepsy in tuberous sclerosis complex. Epilepsia. 2010;51(7):1236-1241. 9 Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342(5):314-319. 10 French JA. Refractory epilepsy: clinical overview. Epilepsia. 2007;48 Suppl 1:3-7. 11 Epilepsy Foundation. Dravet Syndrome. . Accessed November 2023. 12 National Organization for Rare Disorders, Inc. Lennox-Gastaut Syndrome: Signs & Symptoms. . Accessed November 2023. Company Codes: NASDAQ-NMS:JAZZ