On Thursday 25 September, the European Commission announced that it had granted marketing authorisation for Kisunla (donanemab), a drug designed to treat mild cognitive impairment, including mild dementia in the early stages of Alzheimer’s disease.
Kisunla was developed by the pharmaceutical company Eli Lilly and Company. Kisunla is a monoclonal antibody administered by intravenous infusion.
According to the Commission, Kisunla may help to “slow down the progression of cognitive and functional issues associated with Alzheimer’s disease in certain patients”. The authorisation is based on the positive scientific assessment of the European Medicines Agency (EMA), which concluded that the benefits outweighed the risks for a specific population of patients with early-stage Alzheimer’s disease.
Strict conditions of use have been laid down, as Kisunla is considered suitable only for patients with a particular genetic predisposition, along with risk reduction measures (medical monitoring, labelling requirements).
This treatment was approved by the US Food and Drug Administration (FDA) in July 2024. In the EU, following an initial negative assessment by the EMA in March 2025, a reassessment led to a favourable recommendation in July 2025. (Original version in French by Lionel Changeur)