Eli Lilly's Alzheimer's treatment Kisunla wins approval in Japan

By Ciara Linnane

Japan, with its rapidly aging population, is the second country to approve the treatment after the U.S.

Eli Lilly & Co. Inc. said Tuesday the Japanese regulator has approved its Kisunla treatment for adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment and as well as those in the mild-dementia stage of the illness.

The approval from the Ministry of Health, Labor and Welfare makes Japan the second country to approve the treatment after the U.S.

The Food and Drug Administration approved Kisunla in July after a bumpy ride through the U.S. regulatory process. The move added a second treatment option for patients in earlier stages of the disease, after Biogen Inc. (BIIB) and Eisai Co.'s (JP:4523) Leqembi was approved last year.

Leqembi, however, is intended for ongoing treatment, whereas patients taking Kisunla may stop the therapy if their levels of amyloid, a hallmark of Alzheimer's disease, fall below a certain threshold.

Japan, with its rapidly aging population, is expected to have more than 5 million patients with dementia by 2030. Alzheimer's is the most common form of dementia, accounting for more than 67% of cases, according to Lilly (LLY).

Kisunla is administered via once-monthly infusions, while Leqembi is administered via biweekly infusions. Biogen and Eisai are working on a once-monthly maintenance dose for Leqembi.

In a late-stage study, Kisunla reduced amyloid plaques by an average 80% after 12 months of treatment and by 84% after 18 months. Like Leqembi, however, Kisunla has been linked with potentially severe side effects known as amyloid-related imaging abnormalities, which can involve swelling and bleeding in the brain.

Both treatments are expensive. Twelve months of Kisunla treatment, or 13 infusions, will cost $32,000, Lilly said in July. Leqembi's list price is about $26,000 a year.

Lilly's stock was slightly lower but has gained 57% in the year to date, while the SPDR S&P Biotech ETF XBI has gained 9.8% and the S&P 500 SPX has gained 19.9%.

-Ciara Linnane

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09-24-24 1106ET

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