FDA approved label expansion for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo on May 8-9, 2026.
Expands treatment to all adult generalized myasthenia gravis (gMG) patients, including anti-AChR, anti-MuSK, anti-LRP4, and triple seronegative serotypes.
Based on Phase 3 ADAPT SERON study showing rapid, significant, sustained symptom improvements (e.g., MG-ADL score) and consistent safety profile.
Previously limited to anti-AChR antibody-positive patients; now broadest label for gMG.
Argenx is a biopharmaceutical company with Vyvgart generating over $4B in global sales last year.