Johnson & Johnson Receives FDA Approval for Imaavy in Generalized Myasthenia Gravis

Johnson & Johnson today announced that the FDA has approved Imaavy (nipocalimab-aahu) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. The approval was based on results from the Phase 3 VIVACITY-MG3 trial, which demonstrated a statistically significant improvement in the MG-ADL score compared to placebo. Nipocalimab is an anti-FcRn antibody that reduces IgG antibody levels, including the pathogenic autoantibodies that cause gMG. This approval provides patients with gMG a new treatment option.