Lilly’s Donanemab Slows Cognitive Decline; FDA Filing Imminent
Full Approval Sought After Accelerated Nod Denied Previously
Executive Summary
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.
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Lilly’s Donanemab, Now At FDA, Poised To Join Alzheimer’s Armamentarium
Lilly expects US approval of the anti-amyloid therapy by the end of the year. Full Phase III data were detailed at AAIC.
After Leqembi Approval, US FDA In No Rush To Declare Amyloid A Validated Surrogate Endpoint
Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.
Leqembi Approval Opens Door To Alzheimer’s Market For Lilly And Others
Full approval for Leqembi is not only a breakthrough for Eisai and Biogen, it will also give companies and investors greater confidence in investing in more novel Alzheimer’s therapies.