Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Thursday that The Lancet Neurology has published results from the pivotal Phase 3 study of nipocalimab, an investigational FcRn blocker, in adults with generalised myasthenia gravis (gMG).

The study met its primary endpoint, demonstrating significant improvement in the MG-ADL score over 24 weeks. Nipocalimab demonstrated a sustained reduction in autoantibody levels, a key underlying cause of gMG, by up to 75%.

gMG is a chronic, autoimmune disease affecting an estimated 700,000 people worldwide. Nipocalimab, a fully human IgG1 antibody, selectively lowers pathogenic IgG while maintaining a protective immune system. The Phase 3 study showed a significant improvement in MG-ADL scores for patients receiving nipocalimab plus standard of care compared to placebo plus standard of care.

J&J has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of nipocalimab in gMG. The FDA granted Priority Review for nipocalimab based on the findings of the Phase 3 study.