Eli Lilly and Company announced that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer’s disease (AD). The therapy is approved for adults with mild cognitive impairment and mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.

“Kisunla demonstrated meaningful results in people with early symptomatic Alzheimer’s disease by significantly slowing cognitive and functional decline in our Phase 3 TRAILBLAZER-ALZ 2 study,” said Patrik Jonsson, executive vice president and president of Lilly International. “The data shows that the earlier patients are identified, diagnosed, and treated with Kisunla, the greater the response to treatment. This authorization brings a new option to patients in Europe—offering hope and the potential for more time to focus on what matters most.”

Alzheimer’s disease affects an estimated 6.9 million people in Europe, a number projected to nearly double by 2050 as populations continue to age.

Amyloid, a naturally occurring protein, can accumulate in the brain to form amyloid plaques, which are strongly associated with memory and cognitive decline. Kisunla works by helping the body remove this excessive amyloid buildup, thereby slowing disease progression. Clinical evidence shows that treatment with Kisunla may preserve memory, planning and organizational skills, daily independence, and reduce the risk of advancing to the next stage of disease.

Kisunla is the only once-monthly amyloid plaque-targeting therapy with evidence supporting treatment discontinuation once amyloid is reduced to minimal levels. This feature may help reduce both infusion burden and treatment costs while maintaining long-term benefits. Data also demonstrate Kisunla’s ability to significantly reduce disease progression risk over an 18-month period.

The European Commission’s authorization is based on findings from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials. The Phase 3 TRAILBLAZER-ALZ 2 study showed that Kisunla significantly slowed both cognitive and functional decline, while the Phase 3b TRAILBLAZER-ALZ 6 study demonstrated that a gradual titration dosing schedule reduced the incidence of amyloid-related imaging abnormalities (ARIA-E) without compromising amyloid plaque removal or biomarker reduction.

As with other amyloid-targeting therapies, Kisunla is associated with potential side effects such as amyloid-related imaging abnormalities (ARIA), including ARIA-E and ARIA-H. While many cases are asymptomatic, serious and potentially life-threatening complications can occur. Individuals carrying one or two copies of the ApoE4 gene may face increased risk of both Alzheimer’s disease and ARIA. Patients are advised to discuss safety considerations with their healthcare providers.

With this approval, Kisunla provides a new therapeutic option for patients across Europe, offering the possibility to slow disease progression and preserve quality of life during the earliest symptomatic stages of Alzheimer’s disease.