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FDA panel backs Alzheimer's drug that can reportedly slow cognitive decline

If federal regulators agree with the panel's recommendation, donanemab from Eli Lilly could become just the second drug approved in the U.S. to treat patients with Alzheimer's.
Alzheimer's Drug FDA
Posted at 6:25 AM, Jun 11, 2024

A panel of federal health advisers is recommending that the U.S. Food and Drug Administration approve a new medication that may slow the effects of Alzheimer's disease.

The FDA advisory panel voted unanimously to endorse the drug donanemab — produced by Eli Lilly — saying the drug's benefits outweigh the risks and may delay cognitive decline in Alzheimer's patients by several months. However, experts disagree on whether the patients or their loved ones will be able to detect much of a difference, and side effects may include brain swelling or bleeding.

If federal regulators agree with the panel's recommendation, it could become just the second drug approved in the U.S. to treat patients with Alzheimer's. The FDA approved the use of another drug called lecanemab last year that also slows the progression of the disease.

Food and Drug Administration sign

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Lindsey Theis
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"There are other medications being tested as well, but these are the two big medications that you are likely to see in the clinic in the near future," said Dr. Jagan Pillai, an associate professor of neurology at the Cleveland Clinic School of Medicine and cognitive neurologist at the Cleveland Clinic Lou Ruvo Center for Brain Health.

Pillai said the drugs work to slow cognitive decline in early stages of the disease. Both donanemab and lecanemab are given as an IV infusion in a clinical setting and monitored closely.

"I think the best news is that there's more and more choices for people," Pillai said. "[But] I don't think these medications are the answer to everybody's problems."

Around 6.9 million Americans are currently living with Alzheimer's, according to the Alzheimer's Association.