Lilly responds to EU regulatory setback on Alzheimer’s drug donanemab

On March 28, 2025, Eli Lilly and Company announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the company’s request for marketing authorization of donanemab (marketed as Kisunla) for the treatment of early symptomatic Alzheimer’s disease. In response, Lilly stated it will seek a re-examination of the decision.

The company expressed disappointment, emphasizing the urgent need for treatment options in Europe for Alzheimer’s patients. While CHMP did not support approval, donanemab is already approved in the United States, Japan, China, and other markets. Lilly reaffirmed its confidence in the drug's safety and effectiveness.

About Kisunla (donanemab-azbt):

Indication: Approved in the U.S. for adults with early symptomatic Alzheimer's, including mild cognitive impairment or mild dementia.
Dosing: Administered via 30-minute IV infusion once every four weeks.
Key risks: Can cause Amyloid-Related Imaging Abnormalities (ARIA), potentially serious brain swelling or bleeding, especially in patients with the APOE ε4 gene or those on blood thinners.
Common side effects: Headache and infusion-related allergic reactions.

Patients are monitored via MRI scans before and during treatment, and are advised to carry treatment identification due to ARIA risk, which may mimic stroke symptoms.

Lilly reiterated its long-standing commitment to Alzheimer’s research and intends to continue dialogue with European regulators. The company emphasized its broader mission to turn science into healing for people worldwide, including through innovation in neurodegenerative diseases.

For full prescribing information and updates, visit kisunla.lilly.com.