Kisunla approval offers new option to treat early Alzheimer’s in Europe
Treatment found to slow cognitive and functional decline in clinical trial
The European Commission has approved Eli Lilly‘s monthly infusion therapy Kisunla (donanemab) for adults with early symptomatic Alzheimer’s disease.
The treatment targets sticky protein clumps, or amyloid plaques, in the brain and is specifically indicated for people in the early stages of the disease who meet specific pathology and genetic requirements.
The approval covers Kisunla’s use in adults with mild cognitive impairment or mild Alzheimer’s dementia. To be eligible for treatment, patients must have confirmed amyloid pathology — evidence of the disease-driving protein clumps in the brain — and must be heterozygotes or non-carriers of ApoE4 (meaning they carry one or no copies of ApoE4, an Alzheimer’s-associated genetic variation).
“This authorization brings a new option to patients in Europe — offering hope and the potential for more time to focus on what matters most,” Patrik Jonsson, executive vice president and president of Lilly International, said in a company press release.
Global approvals and key studies
European approval of Kisunla comes just over a year after it was approved in the U.S. for a similar indication. It has also been authorized to treat Alzheimer’s in various other countries including the U.K., Japan, China, Qatar, Kuwait, Brazil, Mexico, and Australia.
These approvals were based mainly on data from the pivotal Phase 3 TRAILBLAZER-ALZ 2 study (NCT04437511), which tested Kisunla against a placebo in more than 1,000 adults with early Alzheimer’s. Results showed that Kisunla significantly slowed the decline in multiple measures of cognition and functional ability.
“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. The data shows that the earlier patients are identified, diagnosed, and treated with Kisunla, the greater the response to treatment,” Jonsson said.
The European approval also includes data from the Phase 3b TRAILBLAZER-ALZ 6 trial (NCT05738486), which showed that a modified dosing schedule for Kisunla reduced rates of ARIA-E, a side effect marked by swelling in the brain that usually isn’t serious but can be life-threatening in rare cases.
That modified dosing schedule — which starts with 350 mg for the first infusion, then 700 mg for the second, 1,050 mg for the third, and 1,400 mg for each infusion thereafter — is what’s covered in the European approval. The regimen was approved in the U.S. earlier this year.
Kisunla is designed to reduce levels of amyloid plaques, which are thought to drive Alzheimer’s. According to Lilly, it is the only amyloid-targeting therapy with evidence to support completing a course of treatment once amyloid is reduced to minimal levels, which the company said may reduce infusion burden and treatment costs.
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