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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Lilly Diabetes president Mike Mason is retiring, prompting a shifting of responsibilities among the executive team as the company gears up for key product approvals.
Lilly expects US approval of the anti-amyloid therapy by the end of the year. Full Phase III data were detailed at AAIC.
The company’s anti-amyloid antibody succeeded in Phase III with efficacy at least on par with Eisai/Biogen’s Leqembi, but with ARIA-related deaths unseen with the rival therapy.