FDA — authorised 21 February 2020
- Marketing authorisation holder: Lundbeck Seattle BioPharmaceuticals, Inc.
- Status: approved
🇺🇸 Vyepti in United States
FDA authorised Vyepti on 21 February 2020
Marketing authorisations
FDA — authorised 22 October 2025
- Application: BLA761119
- Marketing authorisation holder: Lundbeck Seattle BioPharmaceuticals, Inc.
- Indication: Efficacy
- Status: approved
The FDA approved Vyepti, a medication for the prevention of migraine, on 22 October 2025. The approval was granted to Lundbeck Seattle BioPharmaceuticals, Inc. under the standard expedited pathway. This approval allows Vyepti to be marketed in the United States for the treatment of migraine prevention.
Vyepti in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Vyepti approved in United States?
Yes. FDA authorised it on 21 February 2020; FDA authorised it on 22 October 2025.
Who is the marketing authorisation holder for Vyepti in United States?
Lundbeck Seattle BioPharmaceuticals, Inc. holds the US marketing authorisation.