FDA — authorised 17 December 2021
- Application: BLA761195
- Marketing authorisation holder: ARGENX BV
- Local brand name: VYVGART
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 efgartigimod administration in United States
FDA authorised efgartigimod administration on 17 December 2021
Marketing authorisation
Frequently asked questions
Is efgartigimod administration approved in United States?
Yes. FDA authorised it on 17 December 2021.
Who is the marketing authorisation holder for efgartigimod administration in United States?
ARGENX BV holds the US marketing authorisation.