Eli Lilly & Co. (NYSE: LLY) has announced that its Alzheimer’s disease (AD) treatment, Kisunla (donanemab), has been granted market approval in Japan. The drug is indicated for adults with early symptomatic AD, including those with mild cognitive impairment (MCI) and/or mild dementia stage, who have confirmed amyloid pathology. Kisunla will be administered in a 350mg/20 mL dosage form via intravenous infusion every four weeks.
This approval marks Kisunla’s entry into its second major market, following its approval by the U.S. FDA in July 2024. The drug is designed to target and remove amyloid plaques in the brain associated with AD. The Japanese approval was based on data from the TRAILBLAZER-ALZ 2 study, which included Japanese participants and showed significant slowing of cognitive and functional decline in those treated with Kisunla. Notably, for patients with less advanced AD, the drug slowed cognitive decline by 35% compared to placebo, as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS), which assesses memory, thinking, and daily functioning. The treatment’s effect was also statistically significant for the overall patient population, with an improvement of 22% on the iADRS.
Kisunla is the latest anti-amyloid therapy to achieve global approvals, following Aduhelm (aducanumab) by Biogen and Eisai, which has since been withdrawn from the market, and Leqembi (lecanemab) by Eisai. Unlike its predecessors, treatment with Kisunla can be discontinued once PET imaging confirms minimal levels of amyloid plaques. In the pivotal global study, 17% of patients were able to stop treatment after 6 months, 47% at 12 months, and 69% at 18 months, translating to potentially lower treatment costs and fewer infusions.
In China, Eli Lilly filed for donanemab’s approval in October 2023, and the drug was granted priority review status in November, with the review process still ongoing.- Flcube.com
