Johnson & Johnson has submitted a biologics license application (BLA) to the FDA for nipocalimab, an investigational treatment targeting generalized myasthenia gravis (gMG), a chronic autoimmune disorder.
The submission is based on data from the phase 3 Vivacity-MG3 study, where nipocalimab, in combination with standard care, provided sustained disease control over 24 weeks for adults with various antibody-positive gMG subtypes. The study covered a broad population of gMG patients and demonstrating consistent, positive results across different subtypes.
Generalized myasthenia gravis is a chronic autoimmune disorder causing muscle weakness due to the immune system attacking acetylcholine receptors. Symptoms include drooping eyelids, double vision, and difficulty swallowing.
Nipocalimab’s mechanism of action involves high-affinity binding to FcRn, which lowers the levels of circulating immunoglobulin G (IgG) antibodies, including harmful autoantibodies, without broadly suppressing the immune system. This targeted approach is intended to reduce the symptoms of gMG while preserving overall immune function.
J&J acquired nipocalimab from Momenta Pharmaceuticals in 2020 for about $6.5 billion, aiming to enhance its portfolio for challenging autoimmune diseases. Nipoclimab belongs to a class of drugs called FcRn antibodies, which analysts at SVBLeerink have estimated could generate $20-25 billion in sales by 2030.
