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

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

 
• By Mandy Jackson

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

Eli Lilly and Company reported late on 19 January that the US Food and Drug Administration issued a complete response letter (CRL) rejecting accelerated approval of donanemab based on the antibody’s ability to clear amyloid from the brains of early Alzheimer’s disease patients in the Phase II TRAILBLAZER-ALZ clinical trial, due to limited long-term data.

Lilly said the FDA issued a CRL “due to the limited number of patients with at least 12 months of drug exposure data” in the company’s application for accelerated approval;

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