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FDA Accepts Eisai s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer s Disease

/PRNewswire/ Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,.

New zealandUnited kingdomUnited statesHaruo naitoChristophera viehbacherMike henckeNatacha gassenbachLibby holmanPrnewswire eisai co ltdCommunications departmentInvestor relations departmentNational institute onMinistry of healthEisai europe ltdAdvisory committeeBiogen inc

FDA Accepts Eisai s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer s Disease

06.03.2023 - Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with a Prescription Drug User Fee Act .

New zealandUnited kingdomUnited statesHaruo naitoChristophera viehbacherMike henckeNatacha gassenbachLibby holmanCommunications departmentInvestor relations departmentNational institute onMinistry of healthEisai europe ltdAdvisory committeeBiogen incPublic relations department

Biogen Inc : Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

TOKYO and CAMBRIDGE, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts

United kingdomUnited statesDennis riedlHaruo naitoChristophera viehbacherMike henckeNatacha gassenbachInvestor relations departmentNational institute onMinistry of healthBiogen incPublic relations departmentNational institutes of healthDrug administrationWashington university school of medicineExchange commission

BIOLOGICS LICENSE APPLICATION FOR LECANEMAB DESIGNATED FOR PRIORITY REVIEW BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION

/PRNewswire/ Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,.

United kingdomUnited statesHaruo naitoChristophera viehbacherMike henckeNatacha gassenbachPrnewswire eisai co ltdInvestor relations departmentNational institute onMinistry of healthBiogen incPublic relations departmentNational institutes of healthDrug administrationEisai incWashington university school of medicine

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United kingdomUnited statesHaruo naitoChristophera viehbacherMike henckeNatacha gassenbachInvestor relations departmentNational institute onMinistry of healthBiogen incPublic relations departmentNational institutes of healthDrug administrationWashington university school of medicineExchange commissionEisai co ltd

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