Johnson & Johnson Announces Positive Phase 3 Results for Nipocalimab in Generalized Myasthenia Gravis

Johnson & Johnson today announced positive results from the Phase 3 VIVACITY-MG3 trial evaluating nipocalimab in adults with generalized myasthenia gravis (gMG). The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared to placebo. Nipocalimab is a fully human anti-FcRn monoclonal antibody that reduces IgG antibody levels, including the pathogenic autoantibodies that cause gMG. The safety profile was consistent with previous studies, with no new safety signals identified. Johnson & Johnson plans to submit a Biologics License Application to the FDA based on these results.