Eli Lilly and Company announced that the European Commission (EC) has approved Kisunla (donanemab) for the treatment of early symptomatic Alzheimer’s disease (AD) in adults. The approval covers patients with mild cognitive impairment or 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."
Amyloid, a protein naturally produced in the body, can accumulate and form plaques in the brain. Excessive amyloid plaque buildup is linked to the memory loss and cognitive decline seen in Alzheimer’s disease. Kisunla helps clear this buildup and slows disease progression, preserving the ability to remember, plan, organize, manage daily activities, and maintain independence longer.
Kisunla is also the only once-monthly amyloid plaque–targeting therapy backed by evidence supporting treatment completion once amyloid is reduced to minimal levels. This may help lower infusion burden and treatment costs. Clinical data show Kisunla significantly slows cognitive and functional decline and reduces the risk of progression to the next clinical stage of the disease over 18 months.
Alzheimer’s currently impacts nearly 6.9 million people in Europe, a number projected to nearly double by 2050 as populations age. Given that about one-third of people in early symptomatic stages progress within one year, there is an urgent need for timely detection, specialist referral, and early intervention.
The EC’s approval is based on results from the Phase 3 TRAILBLAZER-ALZ 2 and Phase 3b TRAILBLAZER-ALZ 6 trials. The TRAILBLAZER-ALZ 2 study confirmed Kisunla’s ability to slow cognitive and functional decline, while the TRAILBLAZER-ALZ 6 study showed that a gradual titration dosing schedule significantly reduced the incidence of amyloid-related imaging abnormalities (ARIA-E) at 24 and 52 weeks, without compromising amyloid clearance or biomarker reduction.
ARIA, which can involve edema/effusion (ARIA-E) or hemorrhage/hemosiderosis (ARIA-H), is a known side effect within this class of therapies. While often asymptomatic, ARIA can sometimes cause serious or even life-threatening effects. Carriers of one or two copies of the ApoE4 gene may face a higher risk of both Alzheimer’s disease and ARIA. Patients are advised to discuss safety considerations with their healthcare providers.