FDA Approves Nipocalimab for Generalized Myasthenia Gravis Treatment

The FDA has approved nipocalimab (Imaavy), a monoclonal antibody developed by Johnson & Johnson, for treating generalized myasthenia gravis (gMG) in adults and adolescents aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. This treatment is the first FcRn-blocker approved for such a broad patient population and is designed to selectively reduce harmful IgG autoantibodies while sparing other immune functions. The approval was based on results from the phase 3 Vivacity-MG3 trial, which showed that nipocalimab plus standard of care led to greater and sustained improvement in disease control and daily functioning compared to placebo, with benefits maintained for up to 20 months in an ongoing extension study. Additionally, in adolescent patients, the drug demonstrated significant reductions in IgG levels and improvements in disease symptoms. Johnson & Johnson has also launched a patient support program to improve access for those prescribed the therapy. Experts and patient advocates highlight the approval as a major milestone, offering new hope for individuals with this unpredictable autoimmune disorder.