European Commission Approves Eli Lilly’s Kisunla for Early Alzheimer’s Disease

Eli Lilly and Company announced that the European Commission has granted marketing authorization for Kisunla (donanemab) to treat adults with early symptomatic Alzheimer’s disease (AD), specifically those with mild cognitive impairment or mild dementia stages and confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers.

Patrik Jonsson, Lilly’s executive vice president and president of Lilly International, highlighted that Kisunla showed meaningful benefits by significantly slowing cognitive and functional decline in the Phase 3 TRAILBLAZER-ALZ 2 trial. He emphasized the importance of early diagnosis and treatment, noting that patients respond better when treated earlier, and that the authorization provides a new treatment option for patients across Europe.

Kisunla targets amyloid plaques—protein clumps in the brain that contribute to memory and thinking difficulties in Alzheimer’s disease—helping the body reduce their excessive buildup. The therapy may slow disease progression and preserve cognitive function and independence longer, addressing key challenges such as remembering information, planning daily tasks, and managing finances.

Kisunla is unique as a once-monthly amyloid plaque-targeting treatment with evidence supporting completion of therapy once amyloid levels are reduced to minimal amounts, potentially lowering infusion burden and treatment costs. Clinical data also showed a significant reduction in the risk of progressing to more advanced disease stages over 18 months.

Alzheimer’s disease currently affects about 6.9 million people in Europe, with numbers expected to nearly double by 2050 due to aging populations. Early detection and treatment are critical since roughly one-third of patients with early symptoms progress to more severe stages within a year.

The EU approval is based on data from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 Phase 3 trials, which confirmed Kisunla’s ability to slow cognitive and functional decline. While the treatment is generally well tolerated, it carries risks typical of its drug class, including amyloid-related imaging abnormalities (ARIA), which may be more frequent in patients carrying the ApoE4 gene. These side effects usually do not cause symptoms but can occasionally be serious.

The dosing regimen follows findings from the TRAILBLAZER-ALZ 6 study, which demonstrated that a gradual dose escalation reduced the incidence of ARIA while maintaining effectiveness in amyloid plaque removal.

This approval marks a significant step forward in offering a new therapeutic option for patients with early Alzheimer’s disease in Europe.