The US Food and Drug Administration’s last-minute decision to call an advisory panel and delay its decision on Eli Lilly and Company’s Alzheimer’s drug donanemab may be due to its need for advice on how to label the drug for optimal use in the “real-world” as opposed to the clinical trial setting, not a signal the agency is wavering on what has been anticipated to be a done licensing deal.
Lilly’s Donanemab Delay: Labeling, Real-World Operationalization May Be Reason For Adcomm
Close watchers of Lilly’s Alzheimer’s drug believe FDA’s last-minute advisory committee request is to deal with how to translate a complicated trial design into label recommendations, not because the agency is thinking of rejecting the drug, which had been seen as a shoo-in for approval.
