Monday, July 24, 2023
UCB, a global biopharmaceutical company, has officially launched RYSTIGGO® (Rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients with positive anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies in the United States. The U.S. Food and Drug Administration (FDA) granted approval to RYSTIGGO under Priority Review on June 26, 2023.
RYSTIGGO is administered through subcutaneous injections by healthcare professionals and is available for order through a limited specialty distribution network. Additionally, UCB provides the "UCB Infusion Finder," an online tool to help patients locate approximately 1,000 infusion locations across the country. The treatment options include infusion at various sites of care, such as physicians' offices, hospital outpatient clinics, and independent infusion centers. UCB has also partnered with selected specialty pharmacies equipped for home infusion to support eligible patients with at-home administration.
Myasthenia gravis is a rare, chronic, autoimmune neuromuscular disease characterized by muscle weakness that worsens with activity and improves with rest. In the United States, an estimated 35,000 to 60,000 individuals are affected by myasthenia gravis, which can lead to symptoms like drooping eyelids, double vision, and difficulties in swallowing, chewing, and talking. The condition's exacerbations can be unpredictable and may cause severe symptoms affecting daily activities.
Kimberly Moran, Ph.D., Head of U.S. Rare Diseases at UCB, highlighted the importance of RYSTIGGO's availability in providing personalized rare disease support to eligible patients. UCB co-created the ONWARD program, designed to assist patients in managing life with this rare disease, in collaboration with input from patients and healthcare providers in the myasthenia gravis community. ONWARD aims to help eligible patients start their prescribed treatment by providing a dedicated Care Coordinator to help them navigate coverage options and explore potential financial assistance.
Samantha Masterson, CEO & President of Myasthenia Gravis Foundation of America, acknowledged the significance of additional FDA-approved targeted treatments, like RYSTIGGO, which offer new possibilities for eligible patients and their treating physicians who may not have found suitable options previously.
Generalized myasthenia gravis is a rare disease with an estimated global prevalence of 100–350 cases per every 1 million people. Patients with this condition experience a range of symptoms, including muscle weakness, drooping eyelids, double vision, and difficulties with speech, swallowing, or talking.
RYSTIGGO® (Rozanolixizumab-noli) is a prescription medicine specifically designed to treat adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (anti-AChR) or muscle-specific tyrosine kinase (anti-MuSK) antibodies.