By Bhanvi Satija and Julie Steenhuysen

June 10 (Reuters) - Outside advisers to the U.S. Food

and Drug Administration will meet on Monday to discuss whether

Eli Lilly's ( LLY ) experimental Alzheimer's drug donanemab is

safe and effective, ahead of the agency's decision on approving

the drug.

The FDA had been expected to rule on the drug earlier this

year but then called for an independent advisory panel to weigh

in. The regulator is not obligated to follow the recommendations

of its outside advisers, but typically does so.

It ran a similar process for the already-approved Leqembi

from Eisai ( ESALF ) and Biogen.

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 that

the benefits of donanemab in slowing cognitive decline in

patients with early stage disease outweigh its safety risks.

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 six 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.