Eli Lilly says FDA delays approval of Alzheimer’s drug in surprise move

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Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.’s shares climbed in early US trading after its experimental drug for Alzheimer’s slowed the progress of the disease in a final-stage trial, paving the way for the company to apply for US approval.
AJ Mast | Bloomberg | Getty Images

Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker’s experimental Alzheimer’s treatment donanemab in a surprise move.

The agency plans to call a last-minute meeting of its outside advisors to further review the treatment’s safety and efficacy in a late-stage trial, Eli Lilly added. The FDA has not disclosed the date of that meeting, so a potential approval would likely come after this month.

The FDA was expected to decide whether to greenlight the medicine by the end of the first quarter. That deadline was already delayed from an expected approval last year. 

The agency’s decision to call for an advisory meeting reflects the high stakes of developing treatments for Alzheimer’s. The condition affects more than six million Americans and currently has no cure, leaving patients who have it with few effective care options. 

It’s another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. Their treatment Leqembi won approval last year, becoming the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. 

Eli Lilly called the delay “unexpected,” but said it is confident in donanemab’s “potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease,” according to a release. 

“We will work with the FDA and the stakeholders in the community to make that presentation and answer all questions,” said Anne White, president of neuroscience at Eli Lilly, in a release.

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