Johnson & Johnson Showcases Promising Nipocalimab Data for gMG at AAN 2025

On March 26, 2025, Johnson & Johnson announced new clinical and real-world data for nipocalimab in the treatment of generalized myasthenia gravis (gMG), ahead of its presentation at the American Academy of Neurology Annual Meeting (April 5–9, 2025). The data reinforce the drug’s potential to deliver long-term disease control for antibody-positive gMG patients and highlight critical unmet needs in the current treatment landscape.

Phase 3 results from the Vivacity-MG3 trial demonstrated sustained improvement in muscle strength and symptom control using both QMG and MG-ADL scores. Patients treated with nipocalimab showed meaningful and durable clinical benefits, which were further supported by findings from the study's open-label extension. Johnson & Johnson filed a Biologics License Application for nipocalimab in August 2024, which is now under U.S. FDA Priority Review.

Additional studies presented at AAN 2025 shed light on challenges faced by patients living with gMG, particularly pregnant women and those using oral corticosteroids. Real-world evidence indicated variability in antibody testing and identified socioeconomic disparities in diagnostic practices. Patient-reported data also revealed that many individuals with gMG experience uncontrolled disease, with factors such as living alone and comorbid mental health conditions contributing to exacerbations.

Nipocalimab, a neonatal Fc receptor (FcRn) blocker, is being studied across multiple autoantibody-related diseases and has received multiple FDA designations for rare and maternal-fetal conditions. Johnson & Johnson emphasized its ongoing commitment to advancing immunoselective therapies and improving care for diverse patient populations affected by autoantibody diseases.