Johnson & Johnson has announced the publication of pivotal Phase 3 study results for nipocalimab, an investigational FcRn blocker, in *The Lancet Neurology*. The Vivacity-MG3 study demonstrated significant and sustained disease control over 24 weeks in antibody-positive adults with generalized myasthenia gravis (gMG). This included up to a 75% reduction in autoantibody levels, a root cause of the disease, with no observed impact on other immune functions. Nipocalimab also showed a tolerable safety profile, with adverse event discontinuation rates comparable to placebo. The investigational therapy has been granted FDA Priority Review for gMG treatment and is currently under review by the European Medicines Agency (EMA).

gMG is a rare, chronic autoantibody-driven neuromuscular disease affecting around 700,000 people globally, with symptoms including muscle weakness, difficulty swallowing, and respiratory challenges. Nipocalimab, a fully human IgG1 monoclonal antibody, selectively reduces IgG autoantibodies that disrupt muscle contractions, potentially addressing the disease's root cause. Johnson & Johnson emphasized the importance of this breakthrough, particularly for patients with limited therapeutic options. The company’s continued commitment to innovative treatments for autoantibody diseases is underscored by nipocalimab's development across multiple conditions, including Sjögren’s disease and hemolytic diseases of the fetus and newborn, further solidifying its potential as a transformative therapy.