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.
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.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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