Johnson & Johnson’s IMAAVY™ (nipocalimab-aahu) Approved by FDA for Generalized Myasthenia Gravis (gMG)

Johnson & Johnson announced on April 30, 2025, that the FDA has approved IMAAVY™ (nipocalimab-aahu), a novel FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG) in both adults and children aged 12 and older who are anti-AChR or anti-MuSK antibody positive.

IMAAVY is the first and only FcRn blocker approved for this broad patient population. The drug demonstrated rapid and sustained reduction in immunoglobulin G (IgG) levels, with pivotal trial data (Vivacity-MG3) showing 20 months of durable disease control. It also met key efficacy and safety endpoints in the pediatric Vibrance-MG trial.

The therapy is administered intravenously and showed consistent safety in both adults and adolescents. A support program, IMAAVY withMe, has been launched to provide access and affordability for eligible U.S. patients.

Nipocalimab is also under investigation for multiple other autoantibody-related conditions and has received several designations from the FDA and EMA, including Fast Track, Orphan Drug, and Breakthrough Therapy status.