Also known as: Vyvgart, VYVGART
The FDA expanded efgartigimod approval to all adult generalized myasthenia gravis serotypes. Phase 3 ADAPT SERON met its primary endpoint and showed no new safety signals.
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
