US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s
Eisai/Biogen’s Leqembi Remains Lone Anti-Amyloid In US
Executive Summary
More long-term data for donanemab needed, FDA says. Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.
You may also be interested in...
US FDA Neuroscience Office In Spotlight With Donanemab Delay, Relyvrio Trial Failure
Lilly’s surprise announcement that the Alzheimer’s drug is going to an advisory committee, followed minutes later by Amylyx’s disclosure that its ALS drug failed a Phase III study, marked a one-two punch of bad news for the Office of Neurosciences’ recent use of regulatory flexibility.
A Lesson In Confidence Amid Development Hurdles: How Lilly Has Talked About Donanemab
The Alzheimer’s disease candidate’s positive milestones, and even its review delays, continue to produce confident statements in its future from the sponsor.
Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short
Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.