US FDA Delays Approval for Experimental Alzheimer’s Drug: What Is Donanemab?

Donanemab slows the progression of Alzheimer’s in patients who are still in the early stages of the disease.

The United States Food and Drug Administration delayed the approval for Eli Lilly’s donanemab, an experimental treatment drug for early Alzheimer’s patients, for the second time, after it rejected an ‘accelerated approval’ request for the drug last year.

Eli Lilly said that the FDA will be discussing the drug’s safety and efficacy with an advisory committee. In a statement, the company said, “It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process.”

It added,

“The date of the advisory committee meeting for donanemab has yet to be set by the FDA, and, as a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024.”