Nipocalimab-aahu, a neonatal Fc receptor (FcRn)–blocking monoclonal antibody, has received FDA approval for treating generalized myasthenia gravis (gMG) in adult and pediatric patients aged 12 years or older who are anti–acetylcholine receptor– (AChR) or anti–muscle-specific kinase (MuSK) antibody–positive. The approval is based on positive results from phase 3 trials, demonstrating significant improvements in MG-ADL scores and a sustained reduction in circulating immunoglobulin G levels in both adult and adolescent patients, with comparable safety and tolerability profiles. Johnson & Johnson plans to pursue regulatory submissions for nipocalimab globally and offers a patient support program to facilitate access to therapy.

Source: Johnson & Johnson