EMA issues positive opinion on donanemab, a new treatment for early-stage Alzheimer’s disease

The European Medicines Agency (EMA) has issued a positive opinion on donanemab, the second treatment targeting beta-amyloid plaques approved in Europe for the treatment of early-stage Alzheimer’s disease. The drug, which will be marketed under the name Kisunla, has been shown in clinical trials to slow cognitive and functional decline in people with mild cognitive impairment or mild dementia.

The recommendation comes after a review process in which the pharmaceutical company Lilly presented new clinical data, including a more tailored dosing regimen and more precise patient selection. The EMA has concluded that, in people with one or no copies of the ApoE4 gene and confirmed amyloid plaque accumulation, the benefits of treatment outweigh the associated risks, such as amyloid-related imaging abnormalities (ARIA).

Donanemab will be administered via monthly infusion (slow, controlled intravenous administration of the drug) in specialized centers and will be subject to a controlled access program, which will ensure safe use supervised by multidisciplinary teams with expertise in Alzheimer’s disease. According to data from the TRAILBLAZER-ALZ 2 clinical trial, the drug can reduce cognitive and functional decline by up to 35% compared to placebo after 18 months of treatment.

In addition, donanemab represents the first anti-amyloid treatment that allows for discontinuation of treatment once plaques have been eliminated, which could reduce the total number of infusions required and decrease the burden of care.

At Ace, we celebrate this advance as a new stage in the approach to and treatment of Alzheimer’s disease. This approval confirms that disease-modifying treatments are now a clinical reality in Europe, after decades without any significant therapeutic advances.

“Drugs such as donanemab represent a paradigm shift: they focus not only on alleviating symptoms, but also on slowing the progression of the disease. However, for them to be effective, it is essential to detect the disease in its very early stages. Now more than ever, our work in early diagnosis is the key that opens the door to these innovative treatments,” emphasizes Dr. Mercè Boada, co-founder and medical director of Ace.

The drug has previously been approved in countries such as the United States, Japan, China, Brazil, and the United Kingdom. The EMA’s decision gives new impetus to Alzheimer’s research and reinforces the need to prepare our healthcare systems to ensure safe, equitable, and effective access to these new therapies.