The U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said.
The U.S.
Food and Drug Administration declined to approve donanemab because Lilly had not submitted data from enough patients who were treated for at least a year, the drugmaker"This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023.
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