Eli Lilly’s Alzheimer’s Drug Approved in Japan, According to Reuters

Eli Lilly has announced that Japan’s health ministry has approved donanemab, its treatment for Alzheimer’s disease, giving patients another option since Eisai and Biogen’s Leqembi received approval in September of the previous year.

Japan marks the second major market to approve the drug, following the United States, where it is marketed under the name Kisunla.

The Alzheimer’s Association estimates that over 4.6 million people in Japan currently live with dementia, a number expected to grow significantly as the population continues to age. Projections from Japan’s National Institute of Population and Social Security Research suggest that individuals aged 65 and older will represent 32.3% of the nation’s population by 2035.

Similar to Leqembi, Kisunla is designed to remove beta-amyloid, a protein associated with Alzheimer’s, from the brain. In a significant late-stage trial, Kisunla was found to slow the decline of memory and cognitive function by 29% compared to a placebo. However, the treatment also caused brain swelling in nearly a quarter of patients and brain bleeding in close to a third, though most incidents were mild.

Kisunla is associated with the strongest safety warning from the FDA in the United States, highlighting the risks of serious brain swelling and bleeding, similar to those observed with Leqembi. Notably, unlike Leqembi, Kisunla has a finite dosing regimen, allowing patients to discontinue treatment once brain scans no longer indicate the presence of amyloid plaques.

A Japanese health ministry panel had recommended the approval of Lilly’s treatment in August.

Alzheimer’s disease is the leading cause of dementia, responsible for approximately 60%-70% of cases, according to the World Health Organization. Lilly projects that by 2030, the number of individuals suffering from dementia in Japan could exceed 5 million.