Unanimous FDA panel backs Lilly Alzheimer's drug
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A unanimous panel of federal drug advisers on Monday concluded that Eli Lilly's experimental Alzheimer's drug donanemab benefits patients with early stages of the disease and that its benefits outweigh its risks.
Why it matters: The pair of 11-0 votes could pave the way for the antibody to become the second drug of its kind to win Food and Drug Administration approval and concurrent Medicare coverage, based on evidence it can slow Alzheimer's progression by about a third.
Context: Donanemab targets proteins in the brain known as amyloid plaques that are believed to contribute to the development of the dreaded neurological condition that afflicts nearly 7 million people in the U.S.
- It would compete with Eisai and Biogen's Leqembi, which the FDA approved last year.
- The FDA called for an outside review of donanemab earlier this year after some patients enrolled in a clinical trial experienced brain swelling, bleeding and other adverse events.
The outside advisers didn't vote on whether the drug should be limited to certain groups of patients. An FDA staff report questioned if levels of protein called tau that builds up in the brains of Alzheimer's patients should be used as a criteria for who gets the drug, which would shrink the potential market.
What they're saying: "This drug has allowed us to live as normal a life as possible within the boundaries of Alzheimer's disease," Sandra Carlino, the wife of a donanemab trial participant, said during the meeting's public comment period.
- Carlino said her husband had an asymptomatic brain bleed during his treatment.
- "The benefits of this therapy far outweigh any adverse event," she said.
What's next: If approved, donanemab "will expand the first class of disease-modifying drugs, serving as the building blocks for future generations of drugs," said Howard Fillit, co-founder and chief science officer of the Alzheimer's Drug Discovery Foundation.
- Joanne Pike, president and CEO of the Alzheimer's Association, pointed to the need for more types of treatments and the possibility of combination therapies that address the complexity of the disease.
- The FDA advisers noted that more data is needed on how the drug performs in underrepresented groups, including Black and Hispanic patients.
