FDA panel 'strongly' supports Biogen (BIIB) and Eisai's Alzheimer's drug Leqembi
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An FDA panel unanimously backed Biogen (NASDAQ: BIIB) and Eisai Alzheimer's drug Leqembi. The panel voted 6-0 in favor of the clinical benefit of the drug.
BMO Capital analysts said the panel vote showed "strong support" for Leqembi.
"Strong support from today's advisory committee in favor of lecanemab's clinical efficacy and level of meaningful benefit with advisors voting unanimously in favor," the analysts commented. "Highlighting the slower rate of decline relative to placebo and noting the -0.45 difference on CDR-SB both as meaningful, especially in the context of placebo only progressing to 1.66. All in there was no question regarding the clinical benefit that patients receive from taking lecanemab for earl Alzheimer's."
The FDA will meet by July 6 to consider regular approval of the drug. The FDA usually follows the guidance of the FDA panel.
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