Pharma Focus Europe

UCB Receives FDA Approval for RYSTIGGO® (Rozanolixizumab-noli) to Treat Adults With Generalized Myasthenia Gravis

Wednesday, June 28, 2023

UCB, a global biopharmaceutical company, has received FDA approval for RYSTIGGO® (rozanolixizumab-noli) as a treatment for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO® is a humanized monoclonal antibody that targets the neonatal Fc receptor (FcRN) to reduce circulating IgG levels, addressing the underlying mechanisms of gMG.

GMG is a rare autoimmune disease characterized by neuromuscular junction dysfunction and damage, leading to muscle weakness and other debilitating symptoms. Current treatment options focus on symptomatic relief, creating a need for innovative therapies to alleviate the burden of the disease.

The FDA approval of RYSTIGGO® is based on the positive results from the Phase 3 MycarinG study. This study demonstrated the efficacy and safety of RYSTIGGO® by measuring improvements in patient-reported outcomes, such as the MG-ADL total score and the Quantitative MG score. The results showed significant differences favoring RYSTIGGO® compared to placebo.

Common adverse reactions reported in patients treated with RYSTIGGO® included headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.

UCB aims to provide personalized disease management options for gMG patients and restore their ability to carry out daily activities. The commercial availability of RYSTIGGO® in the U.S. is expected in the third quarter of 2023.

RYSTIGGO® is currently under review by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), with responses expected in the first half of 2024.

RYSTIGGO® offers a new treatment option for gMG patients and represents a significant milestone in addressing the unmet medical needs of individuals living with this chronic autoimmune neuromuscular disease. UCB is committed to supporting the MG community through education, support, and innovative treatments.

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