In a Surprise Move, FDA Delays Approval For Alzheimer's Drug, Donanemab

The Food and Drug Administration (FDA) has delayed its decision on approving Eli Lilly’s Alzheimer’s drug, donanemab, to seek further advice from its advisory committee. 

Eli Lilly applied for approval in July, following trial data showing the drug slowed Alzheimer’s progression by 29% over 18 months. 

The TRAILBLAZER-ALZ 2 trial was a significant study assessing the safety and efficacy of donanemab in individuals aged 60-85 with early symptomatic Alzheimer’s disease. It was an international trial involving 1,736 participants across eight countries and featured a unique design that included a limited-duration dosing regimen and selected participants based on tau levels.

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Donanemab showed benefits for all participants, with those in earlier stages of the disease experiencing more pronounced effects. About half of the participants completed their treatment within six or twelve months. 

However, the drug was associated with risks like amyloid-related imaging abnormalities (ARIA).

ARIA are side effects seen on brain scans as areas of swelling or bleeding, associated with treatments targeting amyloid in Alzheimer’s disease. While ARIA typically present manageable symptoms, in rare and extreme cases, they could contribute to serious outcomes, including death, especially if accompanied by other health complications.

The move by the FDA to consult its advisory committee was described as “unexpected” by Lilly in a statement.

“The F.D.A. has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design,” the company said in the statement.

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The FDA has made no public comment on the delay and there is no statement of explanation posted on their website. 

Last year, the agency did grant approval for Leqembi and Aduhelm. All three medications are monoclonal antibodies designed to target and reduce amyloid-beta plaques in the brain, a hallmark of Alzheimer’s disease. However, they all differ in their specific formulations, dosing regimens, and clinical trial outcomes. All of them represent a new therapeutic option for slowing the progression of Alzheimer’s disease.

“While it is unusual for an advisory committee to occur after the anticipated FDA action date, the advisory committee meeting for donanemab follows similar meetings for the two other amyloid plaque-targeting therapies the FDA has approved,” the Lily statement read.

Thus far,  the advisory committee’s meeting date remains unscheduled. It will likely postpone the FDA’s decision on the drug until later in the year. The company said that the delay in FDA approval has not affected Eli Lilly’s financial projections for 2024.

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