In surprise move, FDA delays decision on Lilly’s Alzheimer’s drug, will convene advisory committee
The FDA has pushed back its decision on Eli Lilly’s highly anticipated Alzheimer’s drug donanemab and plans to convene an advisory committee to review it, a surprise delay for a treatment that many experts thought would be approved with relative ease.
According to a Lilly press release announcing the delay, the agency has additional questions about donanemab’s safety, the clinical trial design, the decision to take patients off the drug once it clears amyloid plaques from the brain, and Lilly’s stratification of patients based on how much tau protein is in their brain — where higher levels indicate a more advanced disease.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
