Approved for use in the earliest symptomatic stages, Kisunla is the only once-monthly amyloid plaque–targeting therapy with evidence supporting treatment completion once plaques are reduced to minimal levels. The therapy demonstrated significant slowing of cognitive and functional decline in clinical trials, offering patients the potential to preserve independence and delay progression.

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

“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 earlier patients are identified, diagnosed, and treated with Kisunla, the greater the benefit. This authorization brings a much-needed option to patients in Europe—offering hope and the potential for more time to focus on what matters most.”

By targeting and helping clear amyloid plaques, Kisunla slows the progression of Alzheimer’s disease and may preserve memory, daily functioning, and independence longer. It is also the only therapy in its class with clinical evidence supporting treatment discontinuation once amyloid plaques are reduced to minimal levels—potentially lowering infusion burden and treatment costs.

The approval is supported by results from the Phase 3 TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 studies. Data showed Kisunla not only slowed decline over 18 months but also reduced the risk of progressing to the next stage of disease.

Alzheimer’s affects an estimated 6.9 million people in Europe, a number projected to nearly double by 2050. Early detection and intervention are critical, as up to one-third of patients in early symptomatic stages can progress to more advanced stages within a year.