Nipocalimab, developed by Johnson & Johnson (JNJ.US), has shown remarkable improvements in the lives of patients with myasthenia gravis, and it is anticipated to receive regulatory approval this year.

Johnson & Johnson (JNJ.US) today announced that The Lancet Neurology, a sub-journal of The Lancet, has published the results of its pivotal Phase 3 clinical trial, Vivacity-MG3, which evaluated the efficacy of the investigational therapy nipocalimab in adult patients with generalized myasthenia gravis (gMG) who are positive for a wide range of antibodies (anti-AChR, anti-MuSK, and anti-LRP4). The study met its primary endpoint, with a statistically significant and clinically meaningful improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score in patients treated with nipocalimab at 24 weeks. Notably, this therapy was ranked as one of the top 10 potential blockbuster drugs of the year by industry media Evaluate earlier this year. The Phase 3 study data showed that from baseline, nipocalimab can reduce the median level of total IgG by up to 75%. In addition, a significant decrease in the levels of pathogenic IgG (such as anti-AChR antibodies and anti-MuSK antibodies) was observed at 24 weeks. No changes in total IgE, IgA, and IgM were observed, indicating that even after a decrease in pathogenic IgG autoantibody levels, the protective immune system may still function normally. Nipocalimab in combination with standard of care (SOC) significantly outperformed placebo in combination with SOC in MG-ADL response (≥2-point improvement from baseline) (p=0.0213). For gMG patients, a 1- to 2-point change in MG-ADL score from baseline may mean the difference between normal eating to frequent swallowing difficulties, or from shortness of breath at rest to the need for mechanical ventilation. 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 gMG indication. The FDA has granted nipocalimab priority review. In addition, nipocalimab recently received a breakthrough therapy designation from the U.S. FDA for its 2nd phase clinical trial, DAHLIAS, for the treatment of moderate to severe Sjögren's syndrome.