FDA Approves Rystiggo (rozanolixizumab-noli) for the Treatment of Adults with Generalized Myasthenia Gravis

June 27, 2023 - UCB (Euronext Brussels: UCB), a global biopharmaceutical company, has announced Rystiggo (rozanolixizumab-noli) has been approved by the U.S. Food and Drug Administration (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.

gMG is a rare, chronic, heterogeneous (phenotypic and pathogenic), unpredictable autoimmune disease characterized by dysfunction and damage at the neuromuscular junction (NMJ). Several factors are understood to be drivers of gMG disease pathology, including complement-cascade, immune cells, and pathogenic IgG autoantibodies. Pathogenic IgG autoantibodies can impair synaptic transmission at the NMJ by targeting specific proteins on the post-synaptic membrane. This disrupts the ability of the nerves to stimulate the muscle and results in a weaker contraction. gMG has a global prevalence of 100–350 cases per every 1 million people.

Rozanolixizumab-noli injection for subcutaneous infusion is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRN), resulting in the reduction of circulating IgG. It is the only FDA- approved treatment in adults for both anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.

The most common side effects of RYSTIGGO include:

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