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US FDA advisers to review Eli Lilly Alzheimer's drug
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US FDA advisers to review Eli Lilly Alzheimer's drug
Jun 10, 2024 4:41 AM

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.

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