Alzheimer’s disease
Full data for Eli Lilly’s Phase III TRAILBLAZER-ALZ 2 study, presented Monday at the 2023 Alzheimer’s Association International Conference, confirm positive results announced in May.
Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer’s drug development.
Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry.
Thursday, Eisai and Biogen’s Leqembi also became the first disease-modifying treatment for Alzheimer’s to win traditional approval. CMS coverage is expected to begin immediately.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
After an FDA advisory committee unanimously recommended Leqembi’s full approval, questions linger around amyloid-related imaging abnormalities and a potentially cumbersome patient registry.
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.
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