Vyvgart SC (efgartigimod alfa) PDUFA Date (argenx)
FDA PDUFA decision date for Vyvgart SC (efgartigimod alfa) is May 10, 2026. Developed by argenx. Indication: Seronegative generalized myasthenia gravis. Current status: Approved.
Indication
Seronegative generalized myasthenia gravis
Notes
Label expansion for Vyvgart into seronegative gMG population.
Regulatory details
- Company: argenx
- Therapeutic area: Neurology / Immunology
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2026-05-10
- Outcome: Approved