US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s

Eisai/Biogen’s Leqembi Remains Lone Anti-Amyloid In US

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.

PET CT scan of Human Brain (Axial view Positron Emission Tomography)
The FDA wants longer-term data from more patients • Source: Shutterstock

More from New Products

More from Scrip