FDA denies Eli Lilly's Alzheimer's drug an accelerated approval

The FDA asked Eli Lilly to provide more data on its early-stage Alzheimer's drug, donanemab, before it can decide to add it to its accelerated approval program, the drugmaker said Jan. 19. 

Eli Lilly submitted its accelerated approval application based on its phase 2 results, which found a 32 percent slowed cognitive decline. In a letter, the FDA asked for at least 100 patients who received continued treatment for at least 12 months, but "due to the speed of plaque reduction, many patients were able to stop dosing as early as six months of treatment, resulting in fewer than 100 patients receiving 12 months of donanemab," the drugmaker said.

The race for Alzheimer's drugs is heating up as the industry waits for CMS to decide on its coverage plan for Leqembi, the third-ever drug approved by the FDA to treat Alzheimer's disease. A January 2022 report from analytics firm Clarivate listed donanemab as a therapy with the potential of earning $1 billion in annual revenue by 2027. 

Eli Lilly's drug is still in its phase 3 trial and the company said it plans to apply for approval after it publishes the trial's results in mid-2023.

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