Eli Lilly Announces Approval of Kisunla™ in Japan for Alzheimer's Disease
Wednesday, September 25, 2024
Eli Lilly and Company has received approval from the Ministry of Health, Labour and Welfare of Japan for Kisunla™ (donanemab-azbt, 350 mg/20 mL, administered every four weeks via IV infusion).
This Alzheimer's treatment is for adults with early symptomatic Alzheimer's disease (AD), including individuals with mild cognitive impairment (MCI) and those in the mild dementia stage of AD, both with confirmed amyloid pathology.
Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is a targeted therapy designed to address amyloid buildup in patients with early symptomatic AD, particularly those with MCI or mild dementia. The drug, given through intravenous infusion, starts with an initial dose of 700 mg for the first three treatments, followed by a maintenance dose of 1400 mg every four weeks. It has been shown to cause serious side effects, such as amyloid-related imaging abnormalities (ARIA) and infusion-related reactions.
In the TRAILBLAZER-ALZ 2 study, which included participants from Japan, Kisunla delivered significant benefits by slowing cognitive and functional decline in patients with early symptomatic Alzheimer's. This is a vital treatment option for Japan, where Alzheimer's disease represents a growing healthcare challenge due to the aging population.
Amyloid is a naturally occurring protein in the body that can aggregate and form plaques in the brain, contributing to the cognitive and memory issues associated with Alzheimer's disease. Kisunla helps clear these amyloid plaques, which may slow the progression of symptoms like memory loss, difficulties in organizing tasks, managing finances, and performing everyday activities.
Notably, patients treated with Kisunla may be eligible to discontinue therapy once amyloid plaques have been sufficiently cleared, potentially reducing the treatment burden for those who qualify.
Source: lilly.com
