Cyclosporine

Hikma launches Fidaxomicin Tablets in the US London, UK, 15 October 2026 – Hikma Pharmaceuticals PLC (Hikma, Group), a multinational pharmaceutical company, today announced the US launch of Fidaxomicin Tablets in 200mg, expanding its US portfolio. The product is indicated in adults for the treatment of Clostridioides difficile-associated diarrhea (CDAD). Please see below for Important Safety Information and refer to the full Prescribing Information at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d773c5ee-9361-49b0-871b-af34f3f936be "C. difficile infection is a serious and often recurring condition, and hospitals, clinicians and patients need dependable access to effective treatment options," said Hafrun Fridriksdottir, US President and Chief R&D Officer at Hikma. "Fidaxomicin is an important addition to our portfolio, and it helps broaden access to this medicine for patients across the US. We are manufacturing Fidaxomicin Tablets in the US, at our state-of-the-art facility in Columbus, Ohio, furthering Hikma’s position as one of the nation’s largest domestic producers of high-quality essential generic medicines." According to IQVIA, US sales of Fidaxomicin Tablets were approximately $360 million in the 12 months ending June 2026. Hikma supplies a broad range of increasingly complex non-injectable products to the US market. Our Columbus, Ohio facility supports this portfolio, and we are committed to continued investment in US manufacturing. – ENDS – This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P and BBB/stable Fitch) HK-3671 Download full press release Enquiries Hikma Pharmaceuticals PLC Susan Ringdal EVP, Strategic Planning and Global Affairs +44 (0)20 7399 2760/ +44 7776 477050 Steven Weiss US Communications +1 732 788 8279 IMPORTANT SAFETY INFORMATION FOR FIDAXOMICIN TABLETS CONTRAINDICATIONS Fidaxomicin is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with fidaxomicin. If a severe hypersensitivity reaction occurs, fidaxomicin should be discontinued and appropriate therapy instituted. Some patients with hypersensitivity reactions to fidaxomicin also reported a history of allergy to other macrolides. Physicians prescribing fidaxomicin to patients with a known macrolide allergy should be aware of the possibility of hypersensitivity reactions. Not for Use in Infections Other than Clostridioides difficile-Associated Diarrhea (CDAD) Fidaxomicin is not expected to be effective for the treatment of other types of infections. Fidaxomicin should only be used for the treatment of CDAD. Development of Drug-Resistant Bacteria Prescribing fidaxomicin in the absence of proven or strongly suspected C. difficile infection is unlikely to benefit the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The safety of fidaxomicin 200 mg tablets taken twice daily for 10 days was evaluated in 564 adult patients with CDAD in two active-controlled trials with 86.7% of patients receiving a full course of treatment. Thirty-three (33) adult patients receiving fidaxomicin (5.9%) withdrew from trials as a result of adverse reactions. The following adverse reactions were reported in ≥2% of adult patients taking fidaxomicin tablets in controlled trials: Gastrointestinal Disorders: nausea, vomiting, abdominal pain, gastrointestinal hemorrhage Blood and Lymphatic System Disorders: anemia, neutropenia The following adverse reactions were reported in <2% of adult patients taking fidaxomicin tablets in controlled trials: Gastrointestinal Disorders: abdominal distension, abdominal tenderness, dyspepsia, dysphagia, flatulence, intestinal obstruction, megacolon Investigations: increased blood alkaline phosphatase, decreased blood bicarbonate, increased hepatic enzymes, decreased platelet count Metabolism and Nutrition Disorders: hyperglycemia, metabolic acidosis Skin and Subcutaneous Tissue Disorders: drug eruption, pruritus, rash See the Full Prescribing Information for fidaxomicin tablets for more information about these trials. Post Marketing Experience The following adverse reactions have been identified during post-approval use of fidaxomicin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions (dyspnea, angioedema, rash, pruritus) Pediatric use information is approved for Cubist Pharmaceuticals LLC’s DIFICID® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC’s marketing exclusivity rights, this drug product is not labeled with that information. DRUG INTERACTIONS Fidaxomicin and its main metabolite, OP-1118, are substrates of P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract. Cyclosporine Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with fidaxomicin, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range. Concentrations of fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gastrointestinal tract) via P-gp inhibition; however, concomitant P-gp inhibitor use had no attributable effect on safety or treatment outcome of fidaxomicin-treated adult patients in controlled clinical trials. Based on these results, fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended. USE IN SPECIFIC POPULATIONS Pregnancy The limited available data on use of fidaxomicin in pregnant women are insufficient to inform any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Lactation There is no information on the presence of fidaxomicin or its main metabolite, OP-1118, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fidaxomicin and any potential adverse effects on the breastfed infant from fidaxomicin or from the underlying maternal condition. Pediatric Use The safety and effectiveness of fidaxomicin in pediatric patients have not been established in patients younger than 6 months of age. Pediatric use information is approved for Cubist Pharmaceuticals LLC’s DIFICID® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC’s marketing exclusivity rights, this drug product is not labeled with that information. Geriatric Use No overall differences in safety or effectiveness of fidaxomicin compared to vancomycin were observed between younger patients and those 65 years of age and older. PATIENT COUNSELING INFORMATION When fidaxomicin tablets are prescribed to treat a C. difficile infection, patients should be told that, although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by fidaxomicin tablets or other antibacterial drugs in the future. For more information, please see the Full Prescribing Information for fidaxomicin tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. For more information about fidaxomicin tablets, please contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364. Distributed by: Hikma Pharmaceuticals USA Inc.; Berkeley Heights, NJ 07922 DIFICID® is a registered trademark of Merck & Co., Inc. HK-3434-v1

Latest EBGLYSS (lebrikizumab-lbkz) data reinforce durable disease control, less frequent maintenance dosing and reduced topical treatment use in patients with moderate-to-severe atopic dermatitis Exploratory biomarker analysis provides deeper insights on the immunometabolic biology of psoriasis and potential impact of Taltz (ixekizumab) and Zepbound (tirzepatide) vs. Taltz alone in the TOGETHER-PsO study in adults with psoriasis and obesity INDIANAPOLIS, Oct. 5, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will present new data across its dermatology portfolio at the 2026 Fall Clinical Dermatology Conference taking place Oct. 8-11 in Las Vegas. Twenty-one poster presentations provide insights spanning disease control, treatment experience and outcomes across patient populations, demonstrating Lilly's commitment to addressing the everyday burden of chronic dermatologic diseases such as atopic dermatitis, psoriasis and alopecia areata. Key data presentations include EBGLYSS (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis and the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) in psoriasis and obesity or overweight. "For people living with chronic skin conditions, such as atopic dermatitis and psoriasis, the burden can be constant—relentless itch and significant pain that get in the way of daily routines," said Adrienne Brown, executive vice president and president, Lilly Immunology. "The breadth of dermatologic data we're presenting at Fall Clinical highlights our continued focus on addressing the needs of people living with immune and inflammatory conditions and advancing outcomes that matter most to them." New data on EBGLYSS will be presented with 13 poster presentations exploring a range of topics important to atopic dermatitis care, including durable disease control, less frequent maintenance dosing in adolescents and less topical treatment use. Data will also include investigational efficacy and safety findings for EBGLYSS in pediatric patients as young as six months, as well as findings in patients whose disease affects high-impact areas such as the hands and feet. Six presentations on Taltz and Zepbound used concomitantly offer new insights on immunometabolic health at the intersection of psoriasis and obesity. These data include an exploratory biomarker analysis from the TOGETHER-PsO study of adults with moderate-to-severe plaque psoriasis and obesity or overweight with at least one weight-related comorbid condition—helping advance the understanding of the potential interconnected biology between these two chronic conditions. Additionally, long-term durable outcomes with Olumiant (baricitinib) in pediatric patients 12 years of age and older with severe alopecia areata will be presented from the BRAVE-AA-PEDS clinical trial, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata. Key Lilly Presentations at Fall Clinical 2026 Presentations will be available at . Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe. Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. Zepbound is the only FDA-approved dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity management medication. Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. About EBGLYSS (lebrikizumab-lbkz) EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.1,2,3 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is implicated as a primary cytokine tied to the pathophysiology of atopic dermatitis, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.1 The EBGLYSS Phase 3 program in atopic dermatitis consists of seven key global studies evaluating more than 1,600 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), long-term extension (ADjoin) and adolescent open-label (ADore) studies. The program also includes a study assessing the impact of EBGLYSS on vaccine immune response in adults (ADopt-VA). EBGLYSS has been studied in patients with skin of color (ADmirable) and in dupilumab-experienced patients (ADapt). EBGLYSS was approved in the U.S., Japan and Canada in 2024 and in the European Union in 2023. EBGLYSS is a first-line biologic treatment, administered with or without topical corticosteroids, that offers every-four-week (EU and U.S.) or every-eight-week maintenance dosing (U.S.) for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis that is not well-controlled with topical prescription therapies.1 In the U.S., the recommended initial starting dose of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is 250 mg every four weeks or every eight weeks.1 About Taltz (ixekizumab) Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines. Taltz is approved to treat adults with active psoriatic arthritis and adults and children 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Additionally, Taltz is approved for adults with active ankylosing spondylitis, and adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. About Zepbound (tirzepatide) injection Zepbound (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced calorie diet and increased physical activity. About Olumiant (baricitinib) Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Baricitinib is approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Olumiant is also approved for adults and pediatric patients 12 years of age and older with severe AA in the U.S., European Union and Japan. Olumiant is also approved for the treatment of hospitalized adults with COVID-19 in the U.S. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events and Thrombosis. See the full Prescribing Information here.4 In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases. EBGLYSS INDICATION AND SAFETY SUMMARY EBGLYSS® (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids. It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients. Before using Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you: Have a parasitic (helminth) infection. Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS. Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy. Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Possible side effects EBGLYSS can cause serious side effects, including: Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing swelling of the face, lips, mouth, tongue or throat hives itching fainting, dizziness, feeling lightheaded skin rash cramps in your stomach area (abdomen) Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. The most common side effects of EBGLYSS include: eye and eyelid inflammation, including redness, swelling, and itching injection site reactions shingles (herpes zoster) These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or . How to take See the detailed "Instructions for Use" that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes. Use EBGLYSS exactly as prescribed by your healthcare provider. EBGLYSS is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver. If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time. Learn more EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com . This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you. LK CON BS AD APP EBGLYSS®, its delivery device base, and Lilly Support Services™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. TALTZ INDICATIONS AND SAFETY SUMMARY Taltz® (tȯl-ts) is an injectable medicine used to treat: People 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). Adults with active psoriatic arthritis. Adults with active ankylosing spondylitis. Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. It is not known if Taltz is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age. Warnings - Taltz affects the immune system. It may increase your risk of infections, some people have had serious infections, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized from these infections. Do not use Taltz if you have any symptoms of infection, unless your doctor tells you to. If you have a symptom after starting Taltz, call your doctor right away. Your doctor should check you for TB before you start Taltz, and watch you closely for signs of TB during and after treatment with Taltz. If you have TB, or had it in the past, your doctor may treat you for it before you start Taltz. Do not use Taltz if you have had a serious allergic reaction to ixekizumab or any other ingredient in Taltz, such as: swelling of your eyelids, lips, mouth, tongue or throat, trouble breathing, feeling faint, throat or chest tightness, or skin rash. Get emergency help right away if you have any of these reactions. See the Medication Guide that comes with Taltz for a list of ingredients. Severe skin reactions that look like eczema can happen during treatment with Taltz from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with Taltz if you develop severe skin reactions. Tell your doctor if you have any of the following: redness or rash, itching, patches, your skin is dry or feels like leather, blisters or abrasions that ooze or become crusty, small bumps or plaques with scale or crusting. Crohn's disease or ulcerative colitis (inflammatory bowel disease) can start or get worse with Taltz use. Tell your doctor if you have any of these symptoms or if they get worse: stomach pain, diarrhea, and weight loss. You should not get live vaccines while taking Taltz. You should get the vaccines you need before you start Taltz. Common side effects The most common side effects of Taltz include: Injection site reactions Nausea Upper respiratory infections Fungal skin infections Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Before you use Taltz, review these questions with your doctor: Are you being treated for an infection? Do you have an infection that does not go away or keeps coming back? Do you have TB or have you been in close contact with someone with TB? Do you have possible symptoms of an infection such as fever, cough, sores, diarrhea, or other symptoms? Ask your doctor about other possible symptoms. Do you have Crohn's disease or ulcerative colitis? Tell your doctor if: You need any vaccines or have had one recently. You take prescription or over-the-counter medicines, vitamins, or herbal supplements. You are pregnant or planning to become pregnant. It is not known if Taltz can harm an unborn baby. Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to Taltz during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking Taltz, you are encouraged to enroll in the pregnancy registry by calling 1-800-284-1695 or by visiting online at . You are breastfeeding or planning to breastfeed. It is not known if Taltz passes into breastmilk. How to take See the instructions for use that come with Taltz. There you will find information about how to store, prepare, and inject Taltz. Adults may self-inject after receiving training from a healthcare provider. For children 6 to 17 years of age: If your child's healthcare provider decides that you may give Taltz injections at home, you should receive training on the right way to prepare and inject Taltz. Do not try to give Taltz to your child until you have been shown how to inject Taltz. Children should not inject themselves with Taltz. You or an adult caregiver should prepare and give Taltz injections to your child. Learn more Taltz is a prescription medicine available as a 80 mg/mL, 40 mg/0.5mL, 20 mg/0.25mL injection. For more information, call 1-800-545-5979 or go to taltz.lilly.com. This summary provides basic information about Taltz but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Taltz and how to take it. Your doctor is the best person to help you decide if Taltz is right for you. IX CON BS 20AUG2024 U.S. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with: obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen ® : Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Zepbound Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❑ Do you take diabetes medicines, such as insulin or sulfonylureas? ❑ Do you have a history of diabetic retinopathy? ❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? ❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound. Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at [email protected] or visit . How to take Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection. Learn more Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to . This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 01SEP2026 Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. OLUMIANT INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Olumiant® (O-loo-me¯ -ant) is a Janus kinase (JAK) inhibitor used to treat: adults and adolescents 12 years and older with severe alopecia areata. adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated. It is not known if Olumiant is safe and effective in children with juvenile idiopathic arthritis or with severe alopecia areata who are younger than 12 years old. Warnings - Olumiant may cause serious side effects, including: Serious infections, including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you get symptoms of an infection, such as: fever, sweating, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning with urination or urinating more often than normal feeling tired If you get a serious infection, your doctor may stop Olumiant until your infection is controlled. Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors. Cancer and immune system problems. Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor's advice about having your skin checked for skin cancer while taking Olumiant. Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Get emergency help right away if you get any symptoms of a heart attack or stroke while taking Olumiant, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech Blood clots in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant. Allergic reactions. While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious. Tears in the stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits. Low blood sugar (hypoglycemia) in people with diabetes. Low blood sugar, including serious low blood sugar, has happened in people with diabetes after starting Olumiant and other JAK inhibitors. Your doctor may check your blood sugar more often. While taking Olumiant, tell your doctor if you have diabetes and you have signs or symptoms of low blood sugar. Changes in laboratory test results. Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed. Common side effects The most common side effects of Olumiant in people treated for alopecia areata include: upper respiratory tract infections (cold or sinus infections) headache acne increased cholesterol levels increased muscle enzyme levels urinary tract infection increased liver enzyme levels inflammation of hair follicles (folliculitis) tiredness lower respiratory tract infections nausea genital yeast infection low red blood cell count (anemia) low white blood cell count (neutropenia) stomach-area (abdominal) pain shingles (herpes zoster) increased weight The most common side effects of Olumiant in people treated for rheumatoid arthritis include: upper respiratory tract infections (cold or sinus infections) nausea herpes simplex virus infections, including cold sores shingles (herpes zoster) These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects. You can report side effects to the FDA at 1-800-FDA-1088 or . Before using Before you use Olumiant, tell your doctor if you: ❑ Are being treated for an infection, have an infection that won't go away or keeps coming back, or think you have symptoms of an infection. ❑ Have TB or have been in close contact with someone with TB. ❑ Have or had shingles (herpes zoster). ❑ Have or had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs. ❑ Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common. ❑ Are a current or past smoker. ❑ Have or had a heart attack, other heart problems or stroke. ❑ Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system. ❑ Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines. ❑ Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines. ❑ Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. There is a pregnancy exposure registry that monitors women exposed to Olumiant during pregnancy. If you become pregnant during treatment with Olumiant call 1‑800‑284-1695 or visit to report the pregnancy. ❑ Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant. ❑ Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take: a medicine called probenecid. medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection. ❑ Are under age 18. It is not known if Olumiant is safe and effective in children for conditions other than alopecia areata or in children under 12 years of age. How to take Take Olumiant exactly as your doctor says. Take Olumiant once a day by mouth with or without food. Talk to your doctor if you cannot swallow tablets whole. If you take too much Olumiant, call your doctor or poison control center at 1‑800‑222‑1222, or go to the nearest hospital emergency room right away. Learn more Olumiant is a prescription medicine. For more information, call 1-800-545-5979 or go to . This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you. BA CON BS SEP2026 About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about EBGLYSS (lebrikizumab-lbkz) as a treatment for patients with moderate-to-severe atopic dermatitis and reflects Lilly's current beliefs and expectations. However, there can be no assurance that EBGLYSS will achieve Lilly's objectives or that Lilly will execute its strategy as planned. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Endnotes and References 1 EBGLYSS. Prescribing Information. Lilly USA, LLC. 2 Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7 3 Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.10116/j.jmb.2013.01.024 4 Olumiant. Prescribing Information. Lilly USA, LLC. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo