Outside advisers to the U.S. Food and Drug Administration are meeting on Monday to assess whether Eli Lilly’s LLY.N 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 before approving Leqembi from Eisai 4523.T and Biogen BIIB.O.
The meeting, currently underway, will include presentations from both Lilly and FDA representatives.
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 agency’s Teresa Buracchio, said the FDA would be trying to understand how to adapt Lilly’s trial, which included data only on people with a variety of levels of a second Alzheimer’s-related protein called tau – an indicator of brain cell death – to a real world setting.
In documents submitted to the FDA, Lilly argued that tau imaging is not needed to determine who will benefit from the drug.
Buracchio also noted that patients in the trial could stop treatment as soon as brain imaging showed the amyloid plaque was cleared. These elements could affect the prescribing instructions for the drug.
The experts are being asked to discuss whether analyses of trial data 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.
FDA panel reviews Eli Lilly Alzheimer’s drug ahead of agency decision
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.
(REUTERS)