EU Approves Controversial Alzheimer's Medication Kisunla

On September 26, 2025, the European Union authorized the use of Kisunla, a new medication for treating early-stage Alzheimer's disease, including mild dementia. The approval process was highly debated within the medical community, primarily due to the drug's contentious efficacy and potential side effects. Kisunla, developed by the U.S.-based pharmaceutical giant Eli Lilly, contains the active antibody donanemab and is considered a significant breakthrough in Alzheimer's treatment, joining other drugs like Leqembi from Biogen and Esai.

The European Commission granted marketing authorization for Kisunla under strict conditions. It is approved specifically for patients experiencing mild cognitive impairment or early dementia, provided they do not carry genetic mutations that increase the risk of adverse effects such as cerebral hemorrhages and edema. The approval allows EU member states to determine whether and how to reimburse the drug.

This decision follows a pattern of cautious approval for Alzheimer's drugs within the EU. In late 2024, the European Medicines Agency initially refused to approve Leqembi but eventually permitted its use under strict conditions. Similarly, Kisunla was initially rejected before receiving authorization.

While these treatments have demonstrated some effectiveness in clinical trials—marking a notable advancement after decades of limited progress—the benefits have been called into question by experts. The improvements observed are often minimal and accompanied by serious potential side effects, including life-threatening hemorrhages.

Outside the EU, the United Kingdom has approved both drugs but chooses not to reimburse them due to their high costs and modest benefits. In the United States, both medications are authorized, but payment is dependent on private health insurers.

This approval marks a cautious step forward in Alzheimer's management, emphasizing the need for ongoing research to evaluate the long-term benefits and risks of these emerging treatments.

Source