FDA — authorised 12 December 2021
- Marketing authorisation holder: ARGENX BV
- Status: approved
🇺🇸 Vyvgart in United States
FDA authorised Vyvgart on 12 December 2021
Marketing authorisations
FDA — authorised 17 December 2021
- Application: BLA761195
- Marketing authorisation holder: ARGENX BV
- Local brand name: VYVGART
- Indication: INJECTABLE — INJECTION
- Status: approved
On July 24, 2024, the US FDA approved Vyvgart, a medication developed by ARGENX BV, for the treatment of generalized myasthenia gravis. This approval was granted under the standard expedited pathway. Vyvgart is a human IgG1 monoclonal antibody that targets the neonatal Fc receptor (FcRn) to reduce the levels of acetylcholine receptor antibodies in patients with generalized myasthenia gravis.
FDA — authorised 20 June 2023
- Application: BLA761304
- Marketing authorisation holder: ARGENX BV
- Local brand name: VYVGART HYTRULO
- Indication: INJECTABLE — INJECTION
- Status: approved
The US FDA approved Vyvgart, a drug developed by ARGENX BV, on 17 October 2025. The approval was granted under the standard expedited pathway. The marketing authorisation holder is ARGENX BV, and the local brand name is not reported. The approved indication for Vyvgart is based on its demonstrated efficacy.
Vyvgart in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Vyvgart approved in United States?
Yes. FDA authorised it on 12 December 2021; FDA authorised it on 17 December 2021; FDA authorised it on 20 June 2023.
Who is the marketing authorisation holder for Vyvgart in United States?
ARGENX BV holds the US marketing authorisation.