EMA approves marketing authorization for donanemab for early-stage alzheimer’s treatment

The EMA (European Medicines Agency) has granted marketing authorization for donanemab in Europe. Donanemab is a monoclonal antibody developed by Eli Lilly that has shown potential to slow the progression of Alzheimer’s disease in individuals in the early stages. This decision follows a re-examination process initiated by the company, which provided additional data beyond what was assessed in the initial review.

The recommendation is based on results from the phase 3 TRAILBLAZER ALZ 2 clinical trial, which show that donanemab can significantly slow cognitive and functional decline in patients with confirmed beta-amyloid plaque buildup and a diagnosis of mild cognitive impairment or mild dementia. 

The drug is designed to bind to and remove beta-amyloid plaques—one of the hallmark pathological features of Alzheimer’s. The greatest benefits were seen in individuals with low or moderate tau levels, another key biomarker of the disease. The drug has been shown to reduce cognitive and functional decline by up to 35% compared to placebo at 18 months.

Following a prior negative opinion in March 2025, the EMA re-evaluated the clinical data and concluded that, for a restricted population, the benefits outweigh the risks associated with the treatment, such as side effects linked to ARIA (amyloid-related imaging abnormalities).

Donanemab will be available through a controlled access program, focused on ensuring safe and effective use of the treatment. Access will be limited to people with early-stage Alzheimer's disease (mild cognitive impairment or mild dementia) and with prior confirmation of the presence of beta-amyloid plaques in the brain, through specific tests such as PET or cerebrospinal fluid biomarker analysis. In addition, it cannot be administered to patients carrying two ApoE4 alleles, a genetic factor associated with an increased risk of developing the disease.

During treatment, patients must be monitored regularly to detect possible adverse effects that may involve inflammation or cerebral microhemorrhages.

A new milestone in the fight against Alzheimer’s

The approval of donanemab marks a significant milestone in Alzheimer’s treatment and makes it the second drug approved by the EMA that targets disease progression, following the approval of lecanemab in November 2024. This decision reinforces the notion that we are witnessing a paradigm shift in Alzheimer’s research and clinical care, after more than two decades without major therapeutic advances.

Both drugs are part of a new generation of treatments that act on the underlying biological mechanisms of Alzheimer’s, representing a shift from traditional approaches focused solely on symptom relief.

In the words of Dr. Arcadi Navarro, General Director of the Pasqual Maragall Foundation and the Barcelonaβeta Brain Research Center, “The approval of donanemab is hopeful news. Every new treatment approved represents an opportunity to improve the quality of life for people living with early-stage Alzheimer’s and their families. Furthermore, this decision reaffirms the value of biomedical research and opens the door to developing new therapies that could, in the future, stop or even prevent the disease.”

With this approval, Europe joins countries such as the USA, China, Japan, and the UK, which have already approved donanemab for Alzheimer’s treatment. Negotiations will now begin for its inclusion in each EU member state's public health systems.