Eisai has filed to extend the label for its Alzheimer’s disease therapy Leqembi to include a maintenance ... that is specific to the subcutaneous form. In a statement, Eisai and Biogen said ...
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FDA accepts Eisai/Biogen’s BLA for LEQEMBI in early AD treatmentThe company states: “Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has accepted Eisai’s Biologics License Application, BLA, for lecanemab-irmb – U.S. brand name: LEQEMBI ...
The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.
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