Papilledema

Boehringer makes significant investment to improve the affordability of and access to its full range of inhaler products for COPD and asthma Expansive program builds on the company's century-long commitment to patients with respiratory illnesses RIDGEFIELD, Conn., March 7, 2024 /PRNewswire/ -- Boehringer Ingelheim today announced it will cap out-of-pocket costs at $35 per month for eligible patientsi for all the company's inhaler products. Boehringer's new program will dramatically decrease costs at the pharmacy counter for the most vulnerable patients, including those who are uninsured or underinsured. This reinforces the company's long-standing commitment to ensure access to important medicines for patients. "Patients have counted on Boehringer Ingelheim for nearly 140 years to tackle challenges across diseases, including respiratory illnesses," said Jean-Michel Boers, President and CEO, Boehringer Ingelheim USA Corporation. "The U.S. healthcare system is complex and often doesn't work for patients, especially the most vulnerable. While we can't fix the entire system alone, we are bringing forward a solution to make it fairer. We want to do our part to help patients living with COPD or asthma who struggle to pay for their medications. This new program supports patients with predictable, affordable costs at the pharmacy counter. We will also continue to advocate for substantive policy reforms to improve the healthcare system." Starting June 1, 2024, eligible patients will pay no more than $35 a month at retail pharmacies for all Boehringer Ingelheim inhalers, including: Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray Spiriva® HandiHaler® (tiotropium bromide inhalation powder) Spiriva® Respimat® 1.25 mcg (tiotropium bromide) Inhalation Spray Spiriva® Respimat® 2.5 mcg (tiotropium bromide) Inhalation Spray Stiolto® Respimat® (tiotropium bromide and olodaterol) Inhalation Spray Striverdi® Respimat® (olodaterol) Inhalation Spray Boehringer's program builds on the company's long-standing commitment to supporting patients. The company will continue to provide access to free products for eligible patients and comprehensive patient support programs as well. In addition, Boehringer will decrease the list price on some of its inhaler products and will continue providing significant discounts and rebates off the list price of its medicines to insurers, pharmacy benefits managers and other parties, although unfortunately, these reductions are not always passed on to patients. About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at i Terms and conditions apply. Government restrictions exclude people enrolled in federal government insurance programs from co-pay support. ### ATROVENT HFA (ipratropium bromide HFA) INHALATION AEROSOL Indication for Use ATROVENT HFA (ipratropium bromide HFA) Inhalation Aerosol is a prescription maintenance treatment for bronchospasm (airway narrowing) in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Important Safety Information Do not use ATROVENT HFA if you are allergic to ipratropium or any of the ingredients in ATROVENT HFA or to atropine or similar drugs. ATROVENT HFA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA may increase eye pressure which may cause or worsen some types of glaucoma. Do not get the spray into your eyes. The spray may cause eye pain or discomfort, blurred vision, enlarged pupils, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. Dizziness and blurred vision may occur with ATROVENT HFA. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or machinery. ATROVENT HFA may cause difficulty with urination. Symptoms may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. The most common side effects reported with use of ATROVENT HFA were bronchitis, COPD flare-up (exacerbation), shortness of breath and headache. Tell your doctor about all medicines you are taking, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with ATROVENT HFA can increase side effects. Please see full Prescribing Information including Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1‑800‑FDA‑1088. (9/16) CL-AT-0017 Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray Indication for Use COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator. Important Safety Information Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs. COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms. Avoid spraying COMBIVENT RESPIMAT into your eyes. COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma. If you have sudden vision changes, eye pain or visual halos, stop taking COMBIVENT RESPIMAT and call your doctor right away. COMBIVENT RESPIMAT may cause difficulty with urination. Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines. Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Seek medical attention if your treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), thyroid disorder, or diabetes. Also tell your doctor if you are pregnant or nursing. Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression. The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath. Click here for full Prescribing Information and Patient Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-CBR-100003 10.31.2018 SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) Indications SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are long-term, once-daily, prescription maintenance medicines used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT and SPIRIVA HANDIHALER also reduce the likelihood of flare-ups (COPD exacerbations). SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA is not a treatment for sudden symptoms of asthma or COPD. Important Safety Information for SPIRIVA RESPIMAT Do not use SPIRIVA RESPIMAT or SPIRIVA HANDIHALER if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care. Before using SPIRIVA HANDIHALER, tell your doctor if you have a severe allergy to milk proteins. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA, and call your doctor right away or seek emergency medical care. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can increase the pressure in your eyes (acute narrow-angle glaucoma) which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away. Dizziness and blurred vision may occur with SPIRIVA RESPIMAT or SPIRIVA HANDIHALER. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or machinery. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away. The most common side effects reported with SPIRIVA RESPIMAT in patients with COPD include sore throat, cough, dry mouth, and sinus infection. The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma. The most common side effects reported with SPIRIVA HANDIHALER in patients with COPD include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate, and blurred vision. Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HANDIHALER device. Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation. Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder. Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA can increase side effects. Do not use SPIRIVA RESPIMAT and SPIRIVA HANDIHALER together. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA RESPIMAT. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA HANDIHALER. CL-SVR-0048 2.15.2017 STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray APPROVED USE FOR STIOLTO RESPIMAT STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. STIOLTO is not for asthma. Important Safety Information for STIOLTO RESPIMAT Do not use STIOLTO if you have asthma. People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Call your healthcare provider or get emergency medical care if you experience symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO. Do not use STIOLTO more often than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine. STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help. STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. The most common side effects of STIOLTO are runny nose, cough, and back pain. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. STIOLTO and certain other medicines may affect each other. STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. Do not spray STIOLTO into your eyes. Your vision may become blurred and your pupils may become larger (dilated). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT. CL-STO-100022 6.5.2019 STRIVERDI® RESPIMAT® (olodaterol) Inhalation Spray APPROVED USE for STRIVERDI RESPIMAT Striverdi® Respimat® (olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs, 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. Striverdi is not for asthma. Important Safety Information for STRIVERDI RESPIMAT Do not use STRIVERDI if you have asthma. People with asthma who take long‐acting beta2‐agonist (LABA) medicines, such as STRIVERDI RESPIMAT, without also using a medicine called an inhaled corticosteroid (ICS), have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Get emergency medical care if your breathing problems worsen quickly or you use your rescue medicine but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STRIVERDI. Do not use STRIVERDI RESPIMAT more often than prescribed for you by your doctor. Do not use STRIVERDI RESPIMAT with other LABAs. Do not use STRIVERDI for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all of your medical conditions, including heart problems, high blood pressure, seizures, thyroid problems, and diabetes. STRIVERDI RESPIMAT can cause serious side effects including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happen, stop taking STRIVERDI and seek immediate medical help. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. The most common side effects are runny nose, sore throat, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and joint pain. Tell your doctor about all the medicines you take, including prescription and non‐prescription medicines, vitamins, and herbal supplements. STRIVERDI and certain other medicines may affect each other. STRIVERDI is for oral inhalation only. The STRIVERDI cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. Do not spray STRIVERDI into your eyes. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1 ‐ 800 ‐ FDA ‐ 1088. Read the step-by-step patient Instructions for Use for STRIVERDI RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, including Patient Information, and Instructions for Use for STRIVERDI RESPIMAT. CL-STRR-100001 6.5.2019 Media Contact: Michele Baer Human Pharma Communications [email protected] Boehringer Ingelheim 900 Ridgebury Road Ridgefield CT 06877 More information boehringer-ingelheim.com/US SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

ROCKVILLIE, Md. and SUZHOU, China, March 6, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, today announced that the results of two clinical studies of IBI311 (anti-IGF-1R monoclonal antibody),a Phase I trial in healthy subjects and a Phase II trial in patients with thyroid eye disease (TED), in the form of oral presentation at the 39th Asia Pacific Academy of Ophthalmology (APAO) Congress and the 21st International Congress of Endocrinology (ICE), respectively. A Phase I Study of IBI311 (Anti-IGF-1R Monoclonal Antibody) in Chinese Healthy Volunteers Abstract No.: 200683 The oral presentation at the 39th APAO annual meeting was based on a single dose escalation Phase 1 clinical study (NCT05480597) to evaluate the safety and tolerability of a single intravenous infusion of IBI311 in Chinese healthy volunteers. The primary endpoint of the study was safety variables, and secondary endpoints included pharmacokinetic (PK) parameters and immunogenicity results. The results showed that IBI311 was safe and well tolerated, with the most common treatment-emergent AEs being Grade 1 or 2, transient, and most resolving without treatment. All IBI311 dose groups were tested negative for anti-drug antibodies during the study. These indicated that a single intravenous administration of IBI311 at various dose levels in healthy subjects is safe and well tolerated, and the PK profile supports dose selection for subsequent clinical development. A Phase II Study of IBI311 for the Treatment of Thyroid Eye Disease Abstract No.: # 792 The oral presentation at the 21st International Congress of Endocrinology was based on a multicenter, randomized, double-masked, placebo-controlled Phase II study (NCT05795621) to evaluate the efficacy and safety of IBI311 in subjects with moderately to severely active TED. A total of 33 eligible subjects were randomized in a 2: 1 ratio to receive either IBI311 or placebo. The primary endpoint was the proptosis response rate at Week 12 of the study eye (defined as the percentage of subjects with a reduction in proptosis of ≥2 mm from baseline in the study eye without deterioration ≥ 2 mm increase of proptosis in the fellow eye). After 12 weeks, all subjects received IBI311 until Week 21. The results of the study showed: The primary endpoint was achieved: at Week 12, the proptosis responder rate in the study eye was significantly higher in the IBI311 group than in the placebo group (59.1% vs 18.2%, OR=11. 55, P=0. 0309). With continued treatment and follow-up to week 24, the IBI311 treatment group achieved up to 72.7% proptosis responder rate, 3.37 mm reduction in proptosis from baseline, 88.2% diplopia responder rate (defined as diplopia improvement ≥ grade 1). Safety: The overall safety profile of IBI311 was favorable, with the majority of AE being mild or moderate in severity, and no treatment-emergent AE leading to drug discontinuation/interruption in the IBI311 group. These results suggested that IBI311 significantly improves the proptosis in patients with TED in 12 weeks of treatment, and can lead to clinical benefits such as further improvement of proptosis and improvement of diplopia after continuation of treatment, with a favorable safety profile. Professor Xianqun Fan, the leading principal investigator of the study, the Academician of the Chinese Academy of Engineering and professor of ophthalmology at the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, stated, " As an organ-specific autoimmune disease closely related to thyroid disease, TED is one of the most common orbital diseases in adults, and seriously affects the visual function and appearance of patients. At present, there is no targeted therapy approved for the treatment of thyroid ophthalmopathy in China, and the options for therapeutic interventions are limited. IBI311 is currently the most advanced candidate in the clinical development in the TED therapeutic area. As the Principal Investigator of the IBI311 series of studies, I am very pleased to see the progress of IBI311 in TED presented in an oral presentation at the ophthalmology and endocrinology Congress. This is an academic recognition of Chinese studies. I also wish that IBI311 will be approved and available in the clinic in the near future to alleviate the disease burden of Chinese TED patients. " Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are pleased to present the clinical development progress of IBI311 in thyroid eye disease at APAO Congress and ICE. This is another achievement of in-depth collaboration between Innovent and academia. It is also a prestigious recognition by the international ophthalmology and endocrinology academic community to Innovent IBI311's progress in the treatment of thyroid eye disease. We look forward to the approval of IBI311in the near future, providing treatments to TED patients. We will continue to make efforts to facilitate people's pursuit of a happy life and serve more patients." About Thyroid Eye Disease (TED) TED, the most common orbit-related disease in adults, is an autoimmune disease involving ocular tissues and usually associated with Graves' disease (GD) and is the most common orbit-related disease in adults. TED occurs in approximately 25 to 50% of GD patients and can also be seen in other thyroid diseases, even in euthyroidism[1]. The annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in men[2]，and the estimated prevalence of clinically relevant TED ranges from 0.1% to 0.3%[3]. According to disease severity, it can be classified into mild, moderate and severe. Although TED appears to affect women more often, severe cases occur more frequently in men. Patients aged 30 to 50 years are most commonly affected, and severe cases occur more frequently in patients over 50 years[4]. At present, the pathogenesis of TED is not fully understood, but several studies have shown that OFs present in muscle fibers, orbital fibrous connective tissue space are key factors leading to orbital soft tissue enlargement in TED[5]. The natural history of TED is classified into active and inactive phases[6]. The most common symptoms are dry eye, ocular gritty, photophobia, lacrimation, diplopia, and pressure behind the eye, while typical signs include upper eyelid retraction, eyelid edema, periorbital and conjunctival edema, and proptosis. TED is usually mild to moderate, and about 3–5% of patients with TED are severe, manifesting as severe pain, vision-threatening corneal ulcers, or compressive optic neuropathy[7]. In addition to potentially affecting vision, TED can have an extremely severe impact on the patient's appearance and social functioning as well as quality of life. Currently, the first-line treatment for moderately severe active TED is intravenous glucocorticoid therapy, which suffers from unsatisfactory improvement of proptosis and systemic side effects. The second-line treatment includes other immunomodulators, which also have risks related to unclear improvement of proptosis and treatment. Teprotumumab, Tocilizumab and Rituximab are recommended by the Chinese Clinical Diagnosis and Treatment Guidelines for Thyroid Eye Disease (2022)[8], the European Group on Graves' orbitopathy (EUGOGO)[9] and the consensus on thyroid eye disease of the American Thyroid Society and the European Thyroid Society[10] as the second-line treatment options for moderate to severe active TED. Teprotumumab targeting IGF-1R is recommended as first-line therapy for patients with clinically significant proptosis. About IBI311 IBI311 is a recombinant anti-IGF-1R antibody developed by Innovent Biopharmaceuticals for the treatment of TED. IGF-1R, a transmembrane tyrosine kinase receptor that plays a role in development, metabolism, and immune regulation, is overexpressed in OFs, B, and T cells of TED patients[11]. IBI311 can bind IGF-1R, block IGF-1R signaling pathway activation mediated by IGF-1 and other related ligands or agonistic antibodies, thus reducing the expression of downstream inflammatory factors, inhibiting the synthesis of hyaluronic acid and other glycosaminoglycan caused by OFs activation, as well as related inflammatory reactions including tissue congestion and edema. IBI311 can inhibit adipocyte cellularization of OFs, thereby reducing the disease activity of patients with TED and improving proptosis, diplopia, ocular congestion and edema and other symptoms and signs. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 19 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or is otherwise inaccurate. References: SOURCE Innovent Biologics

SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS affecting less than 1,000 people in Europe1 With QALSODY, Biogen has advanced the role of neurofilament in the development of new medicines for ALS, with the potential to accelerate further discovery in the field Feb. 23, 2024 -- Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene. If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND). “The CHMP’s positive opinion reinforces the impact QALSODY can have in SOD1-ALS and further demonstrates Biogen’s commitment to address the unmet needs of people living with ALS and neuromuscular diseases,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We are proud to help pioneer the role of neurofilament in SOD1-ALS clinical trials and are deeply grateful to the people living with SOD1-ALS, their loved ones and study care teams for their dedication to furthering research for the ALS community.” The CHMP’s recommendation for QALSODY is based on the totality of evidence, including the targeted mechanism of action, biomarker and clinical data. In the 28-week Phase 3 VALOR study, reductions of 60% in plasma neurofilament light chain (NfL) were observed in participants who received QALSODY compared to the placebo group, suggesting reduced neuronal injury. Trends towards improvement in the physical abilities of participants who received QALSODY were seen compared to those who received placebo, as measured by the ALS Functional Ratings Scale-Revised (ALSFRS-R). The most common side effects that occurred in ≥10% of QALSODY treated participants and more than the placebo arm were pain, fatigue, fever, joint pain, muscle pain and increased levels of white blood cells and proteins in the cerebrospinal fluid. Serious neurologic events, including myelitis and/or radiculitis; papilledema and elevated intracranial pressure; and aseptic meningitis have also been reported. “The CHMP’s recommendation in support of QALSODY approval provides new hope for the ALS community in Europe,” said Philip Van Damme, M.D., Ph.D., professor of neurology and director of the Neuromuscular Reference Center at the University Hospital Leuven in Belgium. “This is a significant milestone for the entire ALS community - for the first time we have a treatment that led to sustained reductions in neurofilament, a marker of axonal injury and neurodegeneration. The QALSODY development program has provided critical learnings on clinical trial design and the use of biomarkers that is advancing the entire field.” A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but due to the rarity of the disease, it is unlikely that comprehensive data can be obtained under normal conditions of use. The CHMP’s recommendation for QALSODY will now be reviewed by the EC for a decision on a marketing authorization in the European Union, with a decision expected in the second quarter of 2024. QALSODY® (tofersen) is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production. The U.S. Food and Drug Administration granted accelerated approval for QALSODY to treat amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).2 Biogen licensed QALSODY from Ionis Pharmaceuticals, Inc. under a collaborative development and license agreement. QALSODY was discovered by Ionis. In addition to the ongoing open label extension (OLE) of the Phase 3 VALOR study, QALSODY is being studied in the Phase 3, randomized, placebo-controlled ATLAS study to evaluate whether QALSODY can delay clinical onset when initiated in presymptomatic individuals with a SOD1 genetic mutation and biomarker evidence of disease activity (elevated plasma NfL). More details about ATLAS (NCT04856982) can be found at clinicaltrials.gov. Amyotrophic lateral sclerosis (ALS) is a rare, progressive and fatal neurodegenerative disease that results in the loss of motor neurons in the brain and the spinal cord that are responsible for controlling voluntary muscle movement. People with ALS experience muscle weakness and atrophy, causing them to lose independence as they steadily lose the ability to move, speak, eat, and eventually breathe. Average life expectancy for people with ALS is three to five years from time of symptom onset.3 Multiple genes have been implicated in ALS. Genetic testing helps determine if a person’s ALS is associated with a genetic mutation, even in individuals without a known family history of the disease. Mutations in the SOD1 gene are responsible for approximately 2 percent of the estimated 168,000 people who have ALS globally (SOD1-ALS).1 More than 15 percent of people with ALS are thought to have a genetic form of the disease; 4 however, they may not have a known family history of the disease.1 In people with SOD1-ALS, mutations in their SOD1 gene cause their bodies to create a toxic misfolded form of SOD1 protein. This toxic protein causes motor neurons to degenerate, resulting in progressive muscle weakness, loss of function, and eventually, death.4 For over a decade, Biogen has been committed to advancing ALS research to provide a deeper understanding of all forms of the disease. The company has continued to invest in and pioneer research despite making the difficult decision to discontinue a late-stage ALS asset in 2013. Biogen has applied important learnings to its portfolio of assets for genetic and other forms of ALS, with the goal of increasing the probability of bringing a potential therapy to patients in need. These applied learnings include evaluating genetically validated targets in defined patient populations, pursuing the most appropriate modality for each target and employing sensitive clinical endpoints. In addition to QALSODY, the company has a pipeline of investigational drugs being evaluated in ALS, including BIIB105. Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. References: Brown CA, Lally C, Kupelian V, Flanders WD. Estimated Prevalence and Incidence of Amyotrophic Lateral Sclerosis and SOD1 and C9orf72 Genetic Variants. Neuroepidemiology. 2021;55(5):342-353. doi: 10.1159/000516752. Epub 2021 Jul 9. QALSODY Prescribing Information, Cambridge, MA: Biogen. National Institute of Neurological Disorders and Stroke. Amyotrophic Lateral Sclerosis (ALS). Available at: https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als. Accessed: April 2023. Akcimen F, Lopez ER, Landers JE, et al. Amyotrophic lateral sclerosis: translating genetic discoveries into therapies. Nat Rev Genet. 2023. https://doi.org/10.1038/s41576-023-00592-y The content above comes from the network. if any infringement, please contact us to modify.