Johnson & Johnson's Nipocalimab significantly improves the lives of patients with myasthenia gravis and is expected to be approved this year.

Johnson & Johnson (JNJ.US) announced today that the results of its pivotal phase 3 clinical trial Vivacity-MG3 have been published in The Lancet Neurology, a subsidiary journal of The Lancet. This study evaluated the efficacy of the investigational therapy nipocalimab in adult patients with generalized myasthenia gravis (gMG) who were positive for a wide range of antibodies (anti-AChR, anti-MuSK, and anti-LRP4). The study met its primary endpoint, showing statistically significant and clinically meaningful improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scores in gMG patients treated with nipocalimab within 24 weeks. It is worth mentioning that this therapy was listed as one of the top 10 potential breakthrough therapies expected to be on the market this year by the industry media Evaluate earlier this year. The phase 3 study data showed that from baseline, nipocalimab reduced median total IgG levels by up to 75%. Additionally, the study observed significant reductions in levels of pathogenic IgG (such as anti-AChR and anti-MuSK antibodies) within 24 weeks. No changes were observed in total IgE, IgA, and IgM levels, indicating that the protective immune system may still function normally even after a decrease in pathogenic IgG autoantibody levels. Nipocalimab plus standard of care (SOC) showed significantly better results in MG-ADL responses (improvement of 2 points compared to baseline) compared to placebo plus SOC (p=0.0213). For gMG patients, a change of 1 to 2 points in MG-ADL compared to baseline could mean a significant difference from normal eating to frequent swallowing difficulties, or from shortness of breath at rest to the need for a ventilator. The safety and tolerability of nipocalimab were consistent with other study results. Johnson & Johnson submitted a marketing authorization application (MAA) for nipocalimab to the European Medicines Agency (EMA) on September 11, 2024, and a biologics license application (BLA) to the U.S. FDA on August 29, 2024, seeking approval for the indication of gMG. The FDA has granted nipocalimab priority review status. In addition, nipocalimab was recently designated as a breakthrough therapy by the FDA based on the results of its phase 2 clinical trial DAHLIAS for the treatment of severe dry eye syndrome.