(RTTNews) – Eli Lilly and Co. (LLY) announced that the European Commission has approved marketing authorization for Kisunla (donanemab). This new treatment is indicated for adults in the early symptomatic stages of Alzheimer’s disease—including those with mild cognitive impairment or mild dementia—who have confirmed amyloid pathology and are either ApoE4 heterozygotes or non-carriers.
The Kisunla marketing authorization in the European Union is based on the TRAILBLAZER-ALZ 2 and the TRAILBLAZER-ALZ 6 clinical trials. The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated Kisunla significantly slowed cognitive and functional decline. Cognitive and functional decline involves greater memory and thinking problems, affecting daily activities and needing more caregiver support.
Donanemab, a monthly infusion, is currently marketed as Kisunla in the United States and other countries, including Japan, China, United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico and Australia. In the United States, Japan, China and many other countries, donanemab is approved for patients regardless of ApoE4 status. In the European Union, Kisunla is approved for patients who are ApoE4 heterozygotes or non-carriers.
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