Eli Lilly’s Alzheimer’s drug approved in Japan

(Reuters) – Eli Lilly said on Tuesday that Japan's health ministry had approved its Alzheimer's drug donanemab, giving patients another treatment option after Eisai and Biogen's Leqembi received approval in September last year.

Lilly said Japan was the second-largest market where the drug had received approval, after the United States, where it is sold under the same brand name, Kisunla.

According to estimates by the Alzheimer's Association, more than 4.6 million people in Japan suffer from dementia. As the country's population ages, this number is expected to rise significantly.

According to Japan's National Institute for Population and Social Insurance Research, people over 65 are expected to make up 32.3 percent of the country's population in 2035.

Like Leqembi, Lilly's Kisunla is designed to remove a protein linked to Alzheimer's called beta-amyloid from the brain.

In a large late-stage study, Kisunla slowed the progression of memory and thinking problems by 29 percent compared with a placebo. It also caused brain swelling in nearly a quarter of patients and brain bleeding in nearly a third, but most cases were mild.

In the United States, Kisunla is sold on the FDA's strongest safety warning label, warning of the risk of potentially dangerous brain swelling and bleeding, similar to Leqembi.

Unlike Leqembi, Kisunla's dosage is limited, meaning patients can stop treatment once brain scans show no more amyloid plaques.

A panel of the Japanese Ministry of Health recommended approval for Lilly's treatment in August.

Alzheimer's is the most common cause of dementia and accounts for about 60 to 70 percent of all cases, according to the World Health Organization.

Lilly estimates that the number of dementia patients in Japan could rise to over 5 million by 2030.

(Reporting by Puyaan Singh in Bengaluru; Editing by Krishna Chandra Eluri and Vijay Kishore)