US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s
Eisai/Biogen’s Leqembi Remains Lone Anti-Amyloid In US
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.
