Potential breakthrough: FDA panel backs new Alzheimer’s drug, despite side effect risks

Alzheimer’s is a devastating disease that affects millions of families, but there is hope on the horizon.

A panel of FDA advisers voted to endorse a drug from Eli Lilly that could help slow the early progression of Alzheimer’s disease. If approved, “donanemab” would be the second Alzheimer’s drug cleared in the U.S.

There are risks of side effects with the drug. The main ones are brain swelling and bleeding, all of which will have to be monitored.

The FDA typically follows the recommendations of its advisory panels but is not required to. A final decision on approval is expected by the end of July.

Alzheimer’s is a progressive disease that affects memory, thinking and behavior. More than 6 million Americans are living with it, according to the Alzheimer’s Association.

“This is an important development in the ongoing fight to potentially slow the progression of Alzheimer’s disease,” said Dr. John Sims, chief medical officer for the Alzheimer’s Association.

The first drug in this class, Aduhelm, was approved in 2021 despite objections from the FDA’s independent advisers who said it didn’t conclusively show an effect on the brain-destroying disease.

In the case of donanemab, the FDA panel voted 6-0 on Wednesday in favor of a change to the prescribing label that would allow its use in early Alzheimer’s patients.

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