Eli Lilly has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Kisunla (donanemab-azbt) to treat early symptomatic Alzheimer's disease.

A prescription medicine, Kisunla 350mg/20mL intravenous injection is indicated to be used every four weeks in patients with early symptomatic Alzheimer's.

Patients with mild cognitive impairment (MCI) and mild dementia, having confirmed amyloid pathology, are eligible to receive the treatment.

The approval by Japanese authorities is based on the double-blind, placebo-controlled Phase III TRAILBLAZER-ALZ 2 clinical study.

The trial assessed the safety and efficacy of donanemab in 1,736 participants with early symptomatic Alzheimer's across eight countries.

Findings indicated that patients at the earliest stages of the disease responded best to Kisunla treatment.

Patients were monitored over 18 months and divided into two cohorts: those less advanced in their disease progression, and the overall population, which included individuals with higher levels of tau protein.

Kisunla demonstrated a significant reduction in clinical decline in both cohorts.

The treatment reduced the risk of disease progression to the next clinical stage by 9% compared to placebo in the less advanced group.

For the broader participant group, the therapy reduced amyloid plaques by 61%, 80% and 84% at six, 12 and 18 months respectively, from baseline.

Kisunla is associated with serious side effects, such as amyloid-related imaging abnormalities and infusion-related reactions, which will require monitoring.

Eli Lilly and Company Lilly International executive vice-president and president Ilya Yuffa said: “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease by significantly slowing cognitive and functional decline in our TRAILBLAZER-ALZ 2 study, which included participants from Japan.

“The news is another critical step in ensuring patients with Alzheimer's disease can receive treatment with these first class of amyloid therapies, which could give them more time to do what matters most to them.” 

The latest development comes after the company announced Food and Drug Administration approval for EBGLYSS to treat moderate-to-severe atopic dermatitis in adults and children aged 12 years and older.