pharmaphorum March 10, 2024
The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug.
Lilly said the US regulator “wants to further understand topics related to evaluating the safety and efficacy of donanemab,” which includes the safety and efficacy results of its pivotal TRAILBLAZER-ALZ 2 study.
The FDA had been scheduled to deliver a decision before the end of this month, and caused nervousness among investors as they tried to understand the implications of the delay, leading to a 2.3% decline in Lilly’s share price after the news emerged and another 1% fall after hours.
Lilly’s head of neuroscience, Anne White, said the...
Today's Sponsors
Today's Sponsor