On 25 September, the European Commission granted a marketing authorisation for the anti-amyloid drug donanemab, for the treatment of early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia) in adults with confirmed amyloid pathology. This decision applies across all EU Member States.
The European Commission authorisation comes after the European Medicines Agency (EMA) assessment of donanemab’s efficacy and safety, which concluded in July. The EMA’s Committee for Medicinal Products for Human use (CHMP) initially issued a negative opinion on Lilly’s marketing authorisation application for donanemab, in March 2025. After a re-examination process, during which the CHMP considered data on a modified dosing regimen that was able to reduce the incidence of Amyloid-Related Imaging Abnormalities (ARIA; a side effect linked to small brain bleeds or swelling) the Committee issued a positive opinion. In their opinion, the CHMP concluded that the benefits of donanemab outweighed its risks in a restricted patient population, recommending approval for people carrying one or no copies of the apolipoprotein E4 gene, and mandating additional safety measures designed to reduce the risk of ARIA.
The next steps will now take place at national level, where Health Technology Assessment bodies and payers will evaluate the treatment’s value and decide on reimbursement and access conditions.
Read more: https://investor.lilly.com/news-releases/news-release-details/lillys-ki…