The U.S. Food and Drug Administration declined to grant accelerated approval to Eli Lilly and Co.'s (LLY) experimental Alzheimer's drug Donanemab, saying the agency needs safety data on more patients. No other deficiencies in the application were noted.
In the complete response letter to the accelerated approval application, the FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Donanemab's specificity to target deposited amyloid plaque informed the unique clinical trial design of TRAILBLAZER-ALZ, which allowed patients to complete their course of treatment when they reached a predefined level of amyloid plaque clearance.
While the trial included more than 100 patients treated with donanemab, due to the speed of plaque reduction, many patients were able to stop dosing as early as 6 months of treatment, resulting in fewer than 100 patients receiving 12 months of donanemab, Lilly said.
The FDA indicated that the data to meet the exposure expectation would likely need to include the unblinded controlled safety data from TRAILBLAZER-ALZ 2 upon completion.
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer's disease is the most common form of dementia.
The FDA's action does not result in a change to the company's 2023 financial guidance, Lilly said in a statement.
The accelerated approval application was based on Phase 2 trial showing amyloid plaque lowering.
The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in the second quarter of 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter.
The company noted that it will continue to work with the FDA to evaluate the fastest pathway to make the potential treatment option widely available to patients.
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