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Biogen Inc.: FDA Accepts Eisai's Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., June 09, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts
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Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status

TOKYO and CAMBRIDGE, Mass., May 14, 2024 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated the rolling submission of a Biologics License Application to the...
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Eisai Presents New LEQEMBI® (lecanemab-irmb) Investigational Subcutaneous Formulation Interim Study Results and Clinical Improvement Data in Earlier Stages of Early Alzheimer's Disease From Additional Analyses of Clarity AD at The Clinical Trials On Alzheimer's Disease (CTAD) Conference -October 25, 2023 at 05:27 pm EDT

Investigational Subcutaneous Formulation Clears 14% More Plaque Than IV, Pharmacokinetics 11% Higher, And Similar ARIA Rates To IV 76% Of Patients Showed No Decline And 60% Showed Clinical...
United States South Korea United Kingdom New Zealand Great Britain Acta Pharmacol

EISAI PRESENTS NEW LEQEMBI® (LECANEMAB-IRMB) INVESTIGATIONAL SUBCUTANEOUS FORMULATION INTERIM STUDY RESULTS AND CLINICAL IMPROVEMENT DATA IN EARLIER STAGES OF EARLY ALZHEIMER'S DISEASE FROM ADDITIONAL ANALYSES OF CLARITY AD AT THE CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE

INVESTIGATIONAL SUBCUTANEOUS FORMULATION CLEARS 14% MORE PLAQUE THAN IV, PHARMACOKINETICS 11% HIGHER, AND SIMILAR ARIA RATES TO IV 76% OF PATIENTS SHOWED NO DECLINE AND 60% SHOWED CLINICAL...
United States South Korea New Zealand United Kingdom Great Britain Christophera Viehbacher

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Eisai Presents New LEQEMBI® (lecanemab-irmb) Investigational Subcutaneous Formulation Interim Study Results and Clinical Improvement Data in Earlier Stages of Early Alzheimer's Disease From Additional Analyses of Clarity AD at The Clinical Trials On Alzheimer's Disease (CTAD) Conference - Biogen (NASDAQ:BIIB)

Investigational Subcutaneous Formulation Clears 14% More Plaque Than IV, Pharmacokinetics (AUC) 11% Higher, And Similar ARIA Rates To IV 76% Of Patients Showed No Decline And 60% Showed Clinical Improvement At 18
United States South Korea United Kingdom Great Britain Tsujim Protofibrils Haruo Naito

LEQEMBI® Intravenous Infusion (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Japan - Biogen (NASDAQ:BIIB)

TOKYO and CAMBRIDGE, Mass., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO:
South Korea United Kingdom United States Great Britain Christophera Viehbacher Haruo Naito

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