Donanemab Gains EMA Panel Support for Alzheimer’s Treatment

Eli Lilly’s investigational Alzheimer’s treatment, donanemab, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), advancing the therapy toward potential approval in the European Union. EMA’s recommendation could have potential implications for other markets where the treatment is already approved, including Mexico, where it is marketed as Kisunla.

"This positive opinion marks a significant milestone in our efforts to bring donanemab to eligible patients across the European Union," says Patrik Jonsson, Executive VP and President, Lilly International. He adds that the company remains committed to continuing clinical development of the drug.

The recommendation follows data from the Phase 3 TRAILBLAZER-ALZ 2 trial, which showed that donanemab significantly slowed cognitive and functional decline in individuals with early-stage Alzheimer’s disease. In addition, the TRAILBLAZER-ALZ 6 study evaluated a modified dosing schedule that reduced the incidence of amyloid-related imaging abnormalities with edema or effusion (ARIA-E), while maintaining comparable efficacy in amyloid plaque reduction and P-tau217 biomarker improvements.

Donanemab, marketed as Kisunla in the United States, Japan, China, Mexico, and other countries, is an anti-amyloid therapy administered via monthly infusion. In the United States and several other markets, it is approved for patients regardless of ApoE4 status. It is the first amyloid-targeting therapy supported by data permitting treatment discontinuation once amyloid plaques are removed, which may lower costs and reduce overall treatment burden.

Alzheimer’s disease affects about 6.9 million people in the European Union, a figure expected to nearly double by 2050. Progression from mild cognitive impairment or mild dementia to more advanced stages typically occurs within one year for about one-third of patients. Current treatment options remain limited, intensifying demand for disease-modifying therapies.

Like other drugs in its class, donanemab carries safety risks related to ARIA, a known side effect that can lead to brain swelling or bleeding. While typically asymptomatic, ARIA can result in serious outcomes. Genetic carriers of the ApoE4 variant may face increased risk of these side effects, and the therapy requires periodic MRI monitoring. Additional risks include infusion-related reactions and potential allergic responses.

The European Commission will now review the CHMP opinion and is expected to issue a final regulatory decision in the coming months. If approved, donanemab could become part of a broader strategy to intervene earlier in the Alzheimer’s disease continuum, with implications for healthcare systems — including Mexico’s — preparing for rising neurological care needs in aging populations.