Eli Lilly's Early Alzheimer's Treatment Donanemab Scores Japanese Approval, Its Second Largest Market

On Tuesday, The Ministry of Health, Labour and Welfare Japan approved Eli Lilly And Co’s LLY Kisunla (donanemab) for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.

Japan is the second major market in which Kisunla has been approved for use.

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In Japan, by 2030, the number of patients with dementia is estimated to be more than 5 million, and Alzheimer’s is the most common cause of dementia, accounting for more than 67% of cases.

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease.

Kisunla can help the body remove the excessive buildup of amyloid plaques and slow the decline.

The approval is based on the efficacy and safety data from TRAILBLAZER-ALZ 2 Phase 3 clinical study.

Those individuals treated with Kisunla who were less advanced in their disease showed a significant 35% slowing of decline compared with placebo on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures memory, thinking, and daily functioning.

In the overall population, the response to treatment was also statistically significant using the iADRS at 22%. Among the two groups analyzed, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking a placebo.

Among the overall population of participants, Kisunla reduced amyloid plaques on average by 61% at six months, 80% at 12 months, and 84% at 18 months compared to the start of the study.

In the TRAILBLAZER-ALZ 2 study, 66% of patients achieved plaque clearance at one year.

Kisunla can cause amyloid-related imaging abnormalities, which is a potential side effect with amyloid plaque-targeting therapies.

Price Action: LLY stock is trading higher by 0.05% to $919.01 premarket at the last check on Tuesday.

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