FDA — authorised 28 March 2017
- Marketing authorisation holder: REGENERON PHARMACEUTICALS
- Status: approved
🇺🇸 Dupixent in United States
FDA authorised Dupixent on 28 March 2017
Marketing authorisations
FDA — authorised 12 January 2024
- Application: BLA761055
- Marketing authorisation holder: REGENERON PHARMACEUTICALS
- Indication: Efficacy
- Status: approved
The FDA approved Dupixent, a drug developed by Regeneron Pharmaceuticals, on 12 January 2024. The approval was granted under the standard expedited pathway. The approved indication for Dupixent is based on its demonstrated efficacy.
Dupixent 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 Dupixent approved in United States?
Yes. FDA authorised it on 28 March 2017; FDA authorised it on 12 January 2024.
Who is the marketing authorisation holder for Dupixent in United States?
REGENERON PHARMACEUTICALS holds the US marketing authorisation.