FDA — authorised 1 September 2022
- Marketing authorisation holder: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
- Status: approved
🇺🇸 Spevigo in United States
FDA authorised Spevigo on 1 September 2022
Marketing authorisations
FDA — authorised 21 October 2025
- Application: BLA761244
- Marketing authorisation holder: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
- Indication: Labeling
- Status: approved
The FDA approved Spevigo, developed by Boehringer Ingelheim Pharmaceuticals Inc, for its approved indication. This approval was granted through a standard expedited pathway. The application number for this approval is BLA761244.
Spevigo 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 Spevigo approved in United States?
Yes. FDA authorised it on 1 September 2022; FDA authorised it on 21 October 2025.
Who is the marketing authorisation holder for Spevigo in United States?
BOEHRINGER INGELHEIM PHARMACEUTICALS INC holds the US marketing authorisation.