European Commission (EC) granted marketing authorization for Eli Lilly and Company's Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), specifically targeting adults with mild cognitive impairment or mild dementia stages of AD who have confirmed amyloid pathology and are ApoE4 heterozygotes or non-carriers. This approval is a significant breakthrough for the approximately 6.9 million people affected by AD in Europe, offering hope and the potential for patients to maintain cognitive function and independence for longer. and Company's Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), specifically targeting adults with mild cognitive impairment or mild dementia stages of AD who have confirmed amyloid pathology and are ApoE4 heterozygotes or non-carriers. This approval is a significant breakthrough for the approximately 6.9 million people affected by AD in Europe, offering hope and the potential for patients to maintain cognitive function and independence for longer.

Kisunla is an amyloid plaque-targeting therapy that works by helping the body remove the excessive buildup of amyloid plaques—a key pathology in Alzheimer's—which has been shown to significantly slow cognitive and functional decline in the Phase 3 TRAILBLAZER-ALZ 2 study.

A notable feature of Kisunla, which is administered as a monthly infusion, is that it is the only therapy with evidence supporting the completion of the treatment course once amyloid plaques are reduced to minimal levels, which could effectively reduce the overall infusion burden and associated treatment costs. The dosing schedule was refined based on the TRAILBLAZER-ALZ 6 study, which showed that a more gradual titration schedule significantly lowered the incidence of Amyloid-Related Imaging Abnormalities (ARIA)—a common side effect in this class of therapies that can be serious or rarely fatal—while still achieving similar therapeutic results. Patients who are ApoE4 gene carriers are at a higher risk of developing ARIA, and a major caution for the medication includes the risk of ARIA with edema/effusion (ARIA-E) and with hemorrhage/hemosiderosis (ARIA-H), alongside the possibility of serious allergic and infusion-related reactions.

Kisunla is already marketed in the U.S. and several other countries, and this EC authorization is expected to accelerate the availability of this much-needed treatment for earlier-diagnosed patients across the European Union.