UCB announces U.S. FDA approval for ZILBRYSQ® (zilucoplan) autoinjector self-administration for adults living with generalized myasthenia gravis
UCB announces U.S. FDA approval for ZILBRYSQ® (zilucoplan) autoinjector self-administration for adults living with generalized myasthenia gravis |
| [16-October-2026] |
ATLANTA, Oct. 20, 2026 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the first self-administered once-daily autoinjector administration option for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive with ZILBRYSQ® (zilucoplan).¹ The autoinjector is designed to help simplify self-administration of ZILBRYSQ, offering patients another administration option and a more convenient treatment experience.2,3
"This approval is the answer to a question on which we've been relentlessly focused: How do we continue to improve an already effective therapy for daily use?" said Kimberly Moran, PhD, SVP & Head, U.S. Rare Diseases at UCB. "As the first treatment to be approved as a once-daily autoinjector option for adults living with gMG in the U.S., ZILBRYSQ now provides the same therapy via another administration option. At UCB, we are committed to science and make it our point to continually help improve how people experience it." The ZILBRYSQ autoinjector is designed to automatically deliver a pre-defined dose when activated against the skin.1,2 Prior to the autoinjector's approval, ZILBRYSQ was available as a self-administered prefilled syringe (PFS). Patients or their care partners will now have another portable treatment solution. "For a chronic condition like gMG, having different administration options allows patients to choose the approach that best fits their individual preferences and routines," said Donatello Crocetta, Global Head of Medical Affairs and Chief Medical Officer at UCB. "From a medical standpoint, it was essential to confirm that this added administrative option didn't come at the expense of safety and efficacy. The data supporting the autoinjector's complete dose delivery show that this option continues to offer an effective treatment for patients." The approval of the ZILBRYSQ autoinjector for self-administration is supported by data from the following studies:
UCB expects the autoinjector to be available commercially in Q1 2027. *Total autoinjectors used and returned. †Participants defined as patients with gMG or those exhibiting ocular symptoms (injection-experienced and injection-naïve); caregivers (injection-experienced and injection-naïve); and healthcare professionals (HCPs). About ZILBRYSQ®(zilucoplan) The precise mechanism through which ZILBRYSQ exerts therapeutic effects in gMG is unknown. In addition to ZILBRYSQ, UCB's gMG portfolio includes RYSTIGGO® (rozanolixizumab-noli), a subcutaneously infused monoclonal antibody targeting the neonatal Fc receptor (FcRn) approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.6 With two approved medicines with distinct mechanisms of action, UCB continues to offer physicians and the U.S. gMG community a choice of targeted therapies from a single company. The precise mechanism through which RYSTIGGO exerts therapeutic effects in gMG is unknown. About generalized myasthenia gravis (gMG) In gMG, pathogenic autoantibodies can impair synaptic transmission at the neuromuscular junction (NMJ) by targeting specific proteins on the post-synaptic membrane.10 This disrupts the ability of the nerves to stimulate the skeletal muscle and results in a weaker contraction.10 gMG can occur in any race, gender or age.8,9,11 Important Safety Information about ZILBRYSQ® (zilucoplan) in the U.S.1 ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. ZILBRYSQ, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis.
Because of the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ZILBRYSQ REMS. CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ZILBRYSQ REMS Other Infections Pancreatitis And Other Pancreatic Conditions ADVERSE REACTIONS Please see Important Safety Information below and full U.S. Prescribing Information at ZILBRYSQ | UCB. Important Safety Information about RYSTIGGO®(rozanolixizumab-noli) in the US7 RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.13 IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Infections: RYSTIGGO may increase the risk of infection. Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. Immunization Aseptic Meningitis: Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care. Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO. Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after for clinical signs and symptoms of hypersensitivity reactions. If a reaction occurs, institute appropriate measures if needed. ADVERSE REACTIONS Please refer to the full Prescribing Information for additional Important Safety Information. For further information, contact UCB: U.S. Communications Corporate Communications, Media Relations Investor Relations Sahar Yazdian About UCB Forward-looking statements Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, 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, supply chain disruption and business continuity risks; 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 or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring, retention and compliance of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, 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 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, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, 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. References:
ZILBRYSQ® and RYSTIGGO® are a registered trademarks of the UCB Group of Companies.
SOURCE UCB | ||
Company Codes: EuronextBrussels:UCB,EURONEXTBRUSSELS:UCB |
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