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Tag: lecanemab

Eisai Publishes Potential Economic Value of Investigational Lecanemab in Peer-Reviewed Neurology and Therapy Journal

Putri

TOKYO, Jun 22, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its investigational anti-amyloid-beta (Abeta) protofibril antibody lecanemab in people living with early Alzheimer’s disease (AD) using a validated disease simulation model, AD Archimedes Condition […]

Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

Putri

TOKYO and CAMBRIDGE, Mass., May 10, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Abeta) protofibril antibody […]

Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting

Putri

CAMBRIDGE, Mass., and TOKYO, Mar 22, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer’s disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at […]

Biogen and Eisai Amend Collaboration Agreements on Alzheimer’s Disease Treatments

Putri

CAMBRIDGE, Mass., and TOKYO, Mar 15, 2022 – (JCN Newswire via SEAPRWire.com) – Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. announced today that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM (aducanumab-avwa). Effective as of January 1, 2023, Eisai will receive a tiered […]

Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid Beta Protofibril Antibody Lecanemab

Putri

TOKYO, Mar 4, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401). The lecanemab […]

Eisai Presents New Analysis of Lecanemab Clinical Efficacy Results from Phase 2b Study at Clinical Trials On Alzheimer’s Disease (CTAD) Conference

Putri

TOKYO and CAMBRIDGE, Mass., Nov 12, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early […]

Eisai Presents Late-Breaker Updates on Lecanemab Clinical, Biomarker and Safety Data from Phase 2b Study Core and Open-Label Extension

Putri

TOKYO, Nov 11, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer’s disease (AD) from the lecanemab Phase 2b 201 and the open-label extension (OLE) studies. The […]

Eisai Presents New Data on the Relationship Between Clinical, Biomarker and Safety Outcomes from the Lecanemab Phase 2B Study

Putri

TOKYO, Nov 4, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today the presentation of data from the company’s extensive Alzheimer’s disease (AD) pipeline, including six oral presentations that will provide deeper insights into lecanemab’s potential as a treatment for early AD. Eisai initiated a rolling submission of a Biologics License Application […]

Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

Putri

TOKYO, Sep 28, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early […]

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab (BAN2401)

Putri

TOKYO, Jul 30, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) — granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in June 2021 — following 18 months of treatment […]

Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthough Therapy Designation for Lecanemab (BAN2401)

Putri

TOKYO, Jun 24, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease (AD). Breakthrough Therapy designation is an FDA program […]