Accelerated approval from FDA for Leqembi to treat Alzheimer's disease.- Eisai + Biogen
Eisai and Biogen Inc. announced that under the Accelerated Approval Pathway the FDA has approved lecanemab-irmb (Brand Name in the U.S.:Leqembi 100 mg/mL injection for intravenous use), a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta (Abeta) for the treatment of Alzheimer’s disease (AD).
The approval is based on Phase II data that demonstrated that Leqembi reduced the accumulation of Abeta plaque in the brain, a defining feature of AD. Using the recently published data from the large global confirmatory Phase III clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.
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