GENE ONLINE|News &
Eisai and Biogen’s Alzheimer’s Med, Leqembi, Granted FDA Approval
On Saturday, the FDA announced it approved Eisai and Biogen’s jointly developed Alzheimer’s drug, Leqembi, under the accelerated approval program. The approval comes nearly two years after the regulatory agency approved the companies’ previous Alzheimer’s drug, Aduhelm, on the same accelerated pathway before it became the focal point of controversy in biotech. Alongside Leqembi’s accelerated approval, Eisai filed the drug’s supplemental Biologics License Application (sBLA) to gain traditional approval to provide wider access to the drug.
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