ATLANTA, GA — UCB, a global biopharmaceutical company, announced today that ZILBRYSQ® (zilucoplan) is now available in the U.S. for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ was approved by the U.S. Food and Drug Administration (FDA) on October 17, 2023.
ZILBRYSQ is available by prescription as a ready-to-use pre-filled syringe that is a once-daily administration. Healthcare providers who prescribe ZILBRYSQ must enroll in the ZILBRYSQ REMS because of the risk of serious meningococcal infections. Further information is available at www.ZILBRYSQREMS.com or 1-877-414-8353. The most common side effects of ZILBRYSQ include injection site reactions, upper respiratory tract infections, and diarrhea.
Myasthenia gravis is a rare, chronic, autoimmune neuromuscular disease, which is characterized by muscle weakness that worsens after periods of activity and improves after periods of rest. In the U.S., there are 35,000 to 60,000 people living with myasthenia gravis who experience a variety of symptoms, including drooping eyelids, double vision, and difficulty in swallowing, chewing, and talking. Exacerbations are unpredictable and are characterized by potentially severe symptoms affecting activities of daily living.
Now that ZILBRYSQ is approved and commercially available, the ONWARD™ program will be in place to provide further care and support for those navigating the complexities of this disease. With UCB’s two FDA-approved targeted treatment options, which have different mechanisms of action and methods of administration, UCB will continue to deliver on our commitment towards differentiated solutions for this community where there are great unmet needs.
UCB is committed toward our goal to enable affordable access to our medicines for all people who need them, in a way that is sustainable for patients, society, and UCB. Affordability and access are always important to the patient experience when talking about rare disease treatment. Based on the differentiated value of ZILBRYSQ as the first and only FDA-approved self-administered C5 complement inhibitor for AChR+ adults, UCB aimed to price ZILBRYSQ to be the lowest cost complement inhibitor treatment for the U.S. gMG population overall.
ONWARD, a personalized patient support program, will be available to eligible patients and caregivers to provide support throughout their prescribed treatment with medicines within the UCB Rare Disease Portfolio, including ZILBRYSQ and RYSTIGGO.* Through ONWARD, eligible patients will have access to important resources, including a dedicated Care Coordinator† who will provide personalized support, tools, and resources to get started on treatment. This support includes refresher injection coaching and information on symptom tracking and ongoing treatment support, as well as help in understanding insurance coverage. If an eligible patient or caregiver is looking for support, please visit http://www.UCBONWARD.com or call 1-844-ONWARD.
About ZILBRYSQ (zilucoplan)
ZILBRYSQ is a prescription medicine that is used to treat adults with a disease called generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. It is injected under the skin.1
About RYSTIGGO (rozanolixizumab-noli)
RYSTIGGO is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
About UCB
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB).
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