1. Nipocalimab-aahu, a neonatal Fc receptor (FcRn)–blocking monoclonal antibody, is approved for treating generalized myasthenia gravis (gMG) in both adults and pediatric patients.
2. The approval is based on positive results from phase 3 trials demonstrating significant improvements in MG-ADL scores.
3. Nipocalimab reduces pathogenic IgG autoantibodies without affecting other components of adaptive or innate immunity.
4. Safety and tolerability were comparable between adult and pediatric cohorts, with the most commonly reported adverse events being upper respiratory tract infection, peripheral edema, and muscle spasms.

Source: Johnson & Johnson