FDA — authorised 7 June 2021
- Application: BLA761178
- Marketing authorisation holder: BIOGEN INC
- Local brand name: ADUHELM
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Aduhelm in United States
FDA authorised Aduhelm on 7 June 2021
Marketing authorisations
FDA
- Status: approved
Aduhelm 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 Aduhelm approved in United States?
Yes. FDA authorised it on 7 June 2021; FDA has authorised it.
Who is the marketing authorisation holder for Aduhelm in United States?
BIOGEN INC holds the US marketing authorisation.