Eisai Seeks Us Fda Traditional Approval For Leqembi For Treatment Of Alzheimers Disease
Eisai Co., Ltd. And Biogen Inc. Announced Eisai Has Submitted A Supplemental Biologics License Application (Sbla) To The Us Food And Drug Administration (Fda) Supporting The Conversion Of The Accelerated Approval Of Leqembi (Lecanemab-Irmb) 100 Mg/Ml Injection For Intravenous Use To A Traditional Approval. This Sbla Is Subject To Validation Of Whether The Fda Accepts The Application For Review.Leqembi Is A Humanized Immunoglobulin Gamma 1 (Igg1) Monoclonal Antibody Directed Against Aggregated Soluble (Protofibrils) And Insoluble Forms Of Amyloid Beta (A
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