FDA — authorised 6 January 2023
- Marketing authorisation holder: EISAI INC
- Status: approved
🇺🇸 Leqembi in United States
FDA authorised Leqembi on 6 January 2023
Marketing authorisations
FDA — authorised 6 January 2023
- Application: BLA761269
- Marketing authorisation holder: EISAI INC
- Local brand name: LEQEMBI
- Indication: INJECTABLE — INJECTION
- Status: approved
Leqembi 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 Leqembi approved in United States?
Yes. FDA authorised it on 6 January 2023; FDA authorised it on 6 January 2023.
Who is the marketing authorisation holder for Leqembi in United States?
EISAI INC holds the US marketing authorisation.