MHLW Approves Eli Lilly's Kinsula for Alzheimer's in Japan

Eli Lilly has secured approval from Japan's Ministry of Health, Labour and Welfare for Kisunla (donanemab-azbt) as a treatment for early symptomatic Alzheimer’s disease. Kisunla is administered in a 350mg/20mL intravenous injection every four weeks and is intended for patients exhibiting early symptoms of Alzheimer’s, such as mild cognitive impairment (MCI) and mild dementia, contingent upon confirmed amyloid pathology.

The approval is grounded in the results of the Phase III TRAILBLAZER-ALZ 2 clinical trial, which was a double-blind, placebo-controlled study. This extensive trial involved 1,736 participants from eight different countries, all diagnosed with early symptomatic Alzheimer’s disease. The focus of the study was to evaluate both the safety and the effectiveness of donanemab.

Key findings from the study indicated that the treatment was particularly beneficial for patients in the earliest stages of Alzheimer's. The participants were observed over an 18-month period and divided into two main groups: those with less advanced disease progression and a broader group that included individuals with higher levels of tau protein.

For those in the less advanced stage of Alzheimer's, Kisunla significantly slowed clinical decline, reducing the risk of advancing to the next clinical stage by 9% compared to the placebo group. In the broader group of participants, the treatment resulted in a marked decrease in amyloid plaques by 61%, 80%, and 84% at six, 12, and 18 months, respectively, from baseline.

Despite its efficacy, Kisunla is associated with serious side effects, including amyloid-related imaging abnormalities and infusion-related reactions, necessitating careful monitoring of patients undergoing treatment.

Ilya Yuffa, Eli Lilly and Company’s executive vice-president and president of Lilly International, commented on the significance of the approval. He emphasized that Kisunla has shown substantial results in slowing cognitive and functional decline in patients with early symptomatic Alzheimer's in the TRAILBLAZER-ALZ 2 study, which included participants from Japan. Yuffa also highlighted that this development is an essential step toward providing patients with Alzheimer’s disease access to this first class of amyloid therapies, potentially affording them more time to engage in meaningful activities.

This approval in Japan follows Eli Lilly's announcement of receiving the Food and Drug Administration’s nod for EBGLYSS, a treatment for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older.