Dec 17 (Reuters) - China's medical regulator has
approved Eli Lilly's ( LLY ) treatment for early Alzheimer's,
providing patients with another option after Eisai ( ESALF ) and
Biogen's Leqembi received approval in January, the
company said late on Tuesday.
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, Lilly said in a statement.
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, but most cases were mild.
Kisunla is sold with the FDA's strongest "boxed" safety
warning on its prescribing label in the U.S., flagging the risk
of potentially dangerous brain swelling and bleeding, similar to
Leqembi.
However, starting on a more gradual dosing schedule of Kisunla
cut the percentage of patients experiencing potentially serious
brain swelling, the company said.
Additionally, unlike Leqembi, Kisunla has finite dosing,
which allows patients to stop taking the treatment once brain
scans no longer show amyloid plaques.
The treatment is currently under review by the European
Union's drugs regulator. The body in July rejected Leqembi,
saying the risk of serious brain swelling did not outweigh its
small impact on slowing cognitive decline.
Alzheimer's is the most common cause of dementia and accounts
for about 60%-70% of the cases, according to the World Health
Organization.