US FDA advisers to review Eli Lilly Alzheimer’s drug

By Thomson Reuters Jun 10, 2024 | 6:07 AM

By Bhanvi Satija and Julie Steenhuysen

(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 experimental Alzheimer’s drug donanemab.

Donanemab, if approved, would compete with Eisai 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.

(Reporting by Bhanvi Satija in Bengaluru and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)