A highly anticipated Alzheimer’s medication from Eli Lilly gained the support of a federal advisory panel Monday, paving the way for it to become the second drug of its kind authorized in the United States.

An 11-member advisory committee for the Food and Drug Administration voted unanimously Monday afternoon that the drug’s ability to slow disease progression outweighs the drug’s potentially severe side effects, including brain swelling and bleeding.

If the entire FDA were to approve the new medication, donanemab, it would make it the second Alzheimer’s drug the agency approved for use in the U.S., following Leqembi’s approval last year.

The clinical trials for donanemab conducted by Eli Lilly grouped patients based on their levels of tau, a brain protein whose presence predicts the severity of cognitive problems and decline. 

Some FDA reviewers questioned whether it would be necessary to require patients to receive brain scans prior to being prescribed donanemab due to screening for tau levels. Some experts feared, however, that the difficulty of the scans would put the treatment out of reach for patients. They also noted that the evidence showed the efficacy of the drug even with low levels of tau.

Critics of donanemab are concerned about the severity of side effects that may appear, on the surface, to be stroke-like symptoms. The group concluded that it may become part of FDA recommendation guidelines that patients taking donanemab be advised to carry a card indicating that it is on their prescription list to inform physicians in the event of an emergency.

A key difference between donanemab and Leqembi, supporters note, is that Eli Lilly’s drug allows patients to discontinue use when there are very low or no levels of amyloid, a brain plaque that is thought to contribute to Alzheimer’s disease.

“It’s a huge cost savings for the society. We’re talking about expensive treatment, expensive surveillance,” said Dr. Tanya Simuni of Northwestern University at the panel, noting that patients would need to be strictly monitored for deterioration.

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Critics note, though, that Eli Lilly did not provide sufficient data to determine when the best time for patients to discontinue use is or how quickly patients would need to restart treatment

The FDA is expected to make the final decision on the drug’s approval within the year or early next spring.