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
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Experts believe unexpected advisory panel may be used to craft labeling around need for tau imaging and when patients should stop drug. Most analysts still predict approval.
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Lilly told the Pink Sheet that the company and FDA were already engaged in drug labeling discussions prior to the news it would go to an advisory panel
Experts believe the agency may be looking for input given the innovative trial design Lilly used in regards to both
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