J&J seeks FDA nod for chronic autoimmune drug

Johnson & Johnson has officially submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for nipocalimab, an investigational drug designed for the treatment of generalized myasthenia gravis (gMG), a persistent autoimmune disorder. This submission is underpinned by data derived from the phase 3 Vivacity-MG3 study, which demonstrated that nipocalimab, when used alongside standard care, could offer sustained disease control over a 24-week period in adults suffering from various antibody-positive gMG subtypes. The study encompassed a wide array of gMG patients and showcased consistent, favorable outcomes across different subtypes.

Generalized myasthenia gravis is characterized by chronic muscle weakness due to an autoimmune response where the immune system attacks acetylcholine receptors. This attack results in symptoms like drooping eyelids, double vision, and swallowing difficulties.

Nipocalimab operates by binding with high affinity to FcRn, a neonatal Fc receptor, which lowers the levels of circulating immunoglobulin G (IgG) antibodies, including those harmful autoantibodies, without generally suppressing the immune system. This targeted mechanism aims to alleviate the symptoms of gMG while maintaining overall immune function.

Johnson & Johnson acquired nipocalimab from Momenta Pharmaceuticals in 2020 for approximately $6.5 billion, with the goal of bolstering its portfolio of treatments for challenging autoimmune disorders. Nipocalimab is part of a class of drugs known as FcRn antibodies. Analysts at SVBLeerink have projected that these drugs could generate between $20 billion and $25 billion in sales by 2030.

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