Eli Lilly and Co said the U.S. Food and Drug Administration has rejected accelerated approval of its experimental Alzheimer's drug because it did not submit enough trial data from patients who were treated for at least 12 months.
FILE PHOTO: An Eli Lilly and Co pharmaceutical manufacturing plant is pictured in Branchburg, New Jersey -Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year.
The FDA had issued the letter "due to the limited number of patients with at least 12 months of drug exposure data provided in the submission," Eli Lilly said. In the mid-stage trial, patients stopped treatment once their amyloid was cleared - which Lilly said had happened after six months for 40% of patients.
The company said it remained on track to report in the second quarter of this year results from a confirmatory Phase 3 trial of donanemab. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter.
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