Updated: FDA signals likely full approval for Eisai's new Alzheimer's drug ahead of Friday's adcomm
The FDA said Wednesday that the confirmatory trial that Eisai and Biogen ran to show their new Alzheimer’s drug has a clinical benefit did indeed have one, lining Leqembi up for a likely full approval next month after getting an accelerated nod in January.
Ahead of Friday’s advisory committee meeting, which features just six voting members, FDA reviewers affirmed what Eisai and Biogen said at the time about the results of the confirmatory trial, known as CLARITY AD, adding that:
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.