Eli Lilly & Co. (NYSE: LLY) has announced that it has received marketing approval in Great Britain for Kisunla (donanemab), an Alzheimer’s disease (AD) treatment. Kisunla is an intravenous infusion administered every four weeks to eligible adults with mild cognitive impairment and mild dementia due to AD. Eligibility is restricted to apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, aligning with the criteria for currently approved amyloid-targeting therapies in the country.
This approval marks Kisunla’s entry into its third major market, following the U.S. FDA’s approval in July 2024 and Japan’s approval in September 2024.
The TRAILBLAZER-ALZ 2 study, a Phase III, double-blind, placebo-controlled trial, evaluated the safety and efficacy of donanemab in participants with early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease) who had confirmed Alzheimer’s disease neuropathology. The study demonstrated significant slowing of cognitive and functional decline for individuals with early symptomatic Alzheimer’s disease. Donanemab is currently under investigation in multiple clinical trials, including the TRAILBLAZER-ALZ 3 and TRAILBLAZER-ALZ 6 studies.
In China, Eli Lilly filed for donanemab’s approval in October 2023, and the drug was granted priority review status in November of the same year, with the review process still ongoing.- Flcube.com
