FDA — authorised 13 June 2022
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Status: approved
🇺🇸 Amvuttra in United States
FDA authorised Amvuttra on 13 June 2022
Marketing authorisations
FDA — authorised 11 March 2025
- Application: NDA215515
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Indication: Labeling
- Status: approved
The FDA approved Amvuttra, a drug developed by Alnylam Pharmaceuticals Inc, on 11 March 2025. The approval was granted under the standard expedited pathway with application number NDA215515. The approved indication for Amvuttra is listed in its labelling, but the specific indication is not reported in the available data.
Amvuttra 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 Amvuttra approved in United States?
Yes. FDA authorised it on 13 June 2022; FDA authorised it on 11 March 2025.
Who is the marketing authorisation holder for Amvuttra in United States?
ALNYLAM PHARMS INC holds the US marketing authorisation.