FDA — authorised 6 January 2023
- Application: BLA761269
- Marketing authorisation holder: EISAI INC
- Local brand name: LEQEMBI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 LEQEMBI in United States
FDA authorised LEQEMBI on 6 January 2023
Marketing authorisations
FDA — authorised 29 August 2025
- Application: BLA761375
- Marketing authorisation holder: EISAI INC
- Local brand name: LEQEMBI IQLIK
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA
- 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 Neuroscience 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 29 August 2025; FDA has authorised it.
Who is the marketing authorisation holder for LEQEMBI in United States?
EISAI INC holds the US marketing authorisation.