EMA — authorised 15 April 2025
- Application: EMEA/H/C/005966
- Marketing authorisation holder: Eisai GmbH
- Local brand name: Leqembi
- Indication: Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E 4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology (see section 4.4).
- Status: approved
On 15 April 2025, the European Medicines Agency (EMA) granted marketing authorisation for LEQEMBI, a treatment for adult patients with early Alzheimer's disease. This indication is for patients with mild cognitive impairment or mild dementia due to Alzheimer's disease who are either ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. The marketing authorisation holder is Eisai GmbH, and the local brand name is LEQEMBI.