By Bhanvi Satija and Julie Steenhuysen
June 10 (Reuters) - An independent advisory panel to the
U.S. Food and Drug Administration will vote later on Monday on
the safety and effectiveness of Eli Lilly's ( LLY ) experimental
Alzheimer's drug donanemab.
Donanemab, if approved, would compete with Eisai ( ESALF )
and Biogen's Leqembi. Both drugs are designed to remove
toxic beta amyloid plaques from the brains of people with early
Alzheimer's disease.
The antibody treatments, which succeeded in slowing disease
progression in clinical trials, follow three decades of failed
attempts to find drugs to fight the fatal, mind-wasting disease.
The experts are being asked to discuss whether analyses of
trial data to be presented by the FDA and the company show
whether the benefits of donanemab in slowing cognitive decline
in patients with early stage disease outweigh its safety risks.
The FDA is not obligated to follow the recommendations of
its outside advisers but typically does so.
The Lilly drug and others in its class can cause potentially
fatal swelling or bleeding in the brain. Three people in the
donanemab trial died from complications linked to the treatment.
"From the beginning, safety has been a concern with these
new anti-amyloid monoclonal antibodies," said Dr. Joshua Cahan
from Northwestern's Feinberg School of Medicine.
With its approval of Leqembi, the FDA issued its strongest
"boxed" warning about the risk of potentially dangerous brain
swelling and bleeding for the entire class of amyloid-lowering
drugs. FDA drug reviewers said last week that if approved,
donanemab's risks of brain swelling and bleeding would be
described in the boxed warning.
At least four Wall Street analysts said last week that FDA
staff reviewers did not raise any serious red flags and they
expect donanemab to win approval.
Wall Street analysts on average expect donanemab sales of
about $631 million next year, according to LSEG estimates.
More than 6 million Americans have some form of the
memory-robbing condition, according to the Alzheimer's
Association. That figure is projected to rise to nearly 13
million by 2050.