European Medicines Agency recommends approval of Alzheimer's drug Donanemab

The European Medicines Agency (EMA) has recommended the approval of the Alzheimer's drug Donanemab (trade name: Kisunla) in the European Union. The final decision on market launch now rests with the European Commission. Following the EMA's recommendation for lecanemab (trade name: Leqembi) in November 2024, donanemab is now the second drug that not only alleviates symptoms but also directly intervenes in the course of the disease.

Donanemab is an antibody that binds to harmful protein deposits in the brain (so-called beta-amyloid). These deposits are considered one of the main causes of Alzheimer's disease. The treatment is designed to help break down these proteins and thus slow down mental decline in people in the early stages of the disease. Unlike lecanemab, donanemab is not administered permanently, but over a fixed treatment period.

Differences between the antibody therapies

However, in clinical trials, donanemab was associated with more frequent side effects that are visible in the brain – so-called ARIA events. These can include swelling or small bleeds. They were observed in around a quarter of the people treated. 

By comparison, such side effects occurred about half as often with lecanemab. In most cases, the complaints were asymptomatic or mild, but there were also isolated severe cases.

Prof. Gabor Petzold, Head of Clinical Research and Interim Chairman of the Executive Board at the German Center for Neurodegenerative Diseases (DZNE), assesses the EMA's decision as follows:

"The approval of donanemab is good news. It shows that we are making step-by-step progress in the treatment of Alzheimer's disease. Given the previous approval of lecanemab, this step is only logical and now gives patients, their families and doctors a choice between different treatment options.

At the same time, we must keep an eye on the risks. Donanemab causes more side effects in the brain than lecanemab. It is therefore particularly important to select patients carefully and provide them with good support, including detailed counselling and regular check-ups.

A recent decision by the US Food and Drug Administration (FDA) is also significant in this regard: a few days ago, it approved an adjusted dosage regimen for donanemab that significantly reduces the risk of such side effects while maintaining the same efficacy. I am confident that this approach will also be adopted in Europe.

Even though donanemab does not cure the disease, it is another important step forward. We are gaining experience, improving clinical implementation and laying the scientific foundations for future therapies. However, it is now crucial that we continue to research new forms of therapy systematically and collaboratively. This is the only way we will move closer to a future in which Alzheimer's can be controlled."

According to estimates, up to 20,000 people in Germany meet the requirements for treatment with antibodies such as donanemab and lecanemab each year and are also willing to undergo treatment. This represents approximately 10 percent of the population who are in the early stages of the disease and whose genetic makeup meets the criteria for ApoE4 status.

^{July 2025}