Neuroscience
Neurologist David Weisman, with financial ties to the companies, was removed from the FDA’s upcoming advisory committee meeting slated to consider Leqembi’s traditional approval.
The FDA has three high-profile events this week, including one target action date and two advisory committee meetings—one to discuss potential traditional approval for Alzheimer’s drug Leqembi.
While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi.
The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter.
Clinical results for experimental treatments in Alzheimer’s, ALS and more are expected over the coming months. BioSpace highlights a few of the more highly anticipated datasets.
With data from the Phase III trial of donanemab expected in Q2, Eli Lilly presented the first clinical results from its next anti-amyloid antibody, remternetug, at AD/PD 2023.
BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
Data released Wednesday from the Phase III A4 study showed solanezumab fell short of its primary endpoint, failing to slow cognitive decline in patients with preclinical Alzheimer’s disease.
The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.
Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.
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