Kisunla (donanemab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- donanemab
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Alzheimer Disease; Cognitive Dysfunction
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 24 Sep 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006024
- ATC
- N06DX05
- Official record
- www.ema.europa.eu
Indication
Donanemab 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 symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers with confirmed amyloid pathology (see section 4.4).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.