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Lilly’s Donanemab Delay: Labeling, Real-World Operationalization May Be Reason For Adcomm

 
• By Sarah Karlin-Smith

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.

document with "delayed" stamped on it
Lilly's donanemab approval for Alzheimer's is delayed due to last minute advisory committee • Source: Shutterstock

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.

Key Takeaways

  • Experts believe unexpected advisory panel may be used to craft labeling around need for tau imaging and when patients should stop drug. Most analysts...

Experts believe the agency may be looking for input given the innovative trial design Lilly used in regards to both who to enroll and when to stop treatment.

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