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FDA Panel Endorses Eli Lilly’s Experimental Alzheimer’s Drug Donanemab

Eli Lilly Corporate Center

the staff of the Ridgewood blog

Ridgewood NJ, in a significant development, outside advisers to the U.S. Food and Drug Administration (FDA) unanimously endorsed the efficacy of Eli Lilly’s experimental Alzheimer’s drug, donanemab, for patients with early Alzheimer’s disease. This vote precedes the FDA’s impending decision on the drug’s approval. The panel’s discussion highlighted some unique aspects of Lilly’s trial, which differed notably from the trial design of Eisai and Biogen’s Leqembi, another Alzheimer’s drug that recently gained U.S. approval following a similar advisory committee review.

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FDA Approves Alzheimer’s Drug Leqembi , Slowed Cognitive Decline in Clinical Trial

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the staff of the Ridgewood blog

Washington DC,  the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease.

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