China's Alzheimer's Treatment Approved

(Reuters) – China's medical regulator has approved Eli Lilly (NYSE:LLY)'s treatment for early Alzheimer's, providing patients with another option after Eisai and Biogen (NASDAQ:BIIB)'s Leqembi received approval in January.

China is the fourth major market in which the treatment, sold under the brand name Kisunla, has received approval after the United States, Japan, and the UK.

Like Leqembi, Lilly's Kisunla is designed to clear an Alzheimer's-related protein called beta-amyloid from the brain.

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

Kisunla carries the FDA's strongest "boxed" safety warning in the U.S., flagging risks of dangerous brain swelling and bleeding, similar to Leqembi. However, starting with a more gradual dosing schedule reduced the occurrence of serious brain swelling.

Additionally, unlike Leqembi, Kisunla has finite dosing, allowing patients to stop treatment once brain scans no longer show amyloid plaques.

The treatment is under review by the European Union's drug regulator, which previously rejected Leqembi, arguing the risk of serious brain swelling did not outweigh its minimal effect on cognitive decline.

Alzheimer's is the most common cause of dementia, accounting for about 60%-70% of cases, according to the World Health Organization.