lecanemab – Singapura Now

Lecanemab Receives Priority Review Status in Japan

TOKYO and CAMBRIDGE, Mass., Jan 30, 2023 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (Abeta) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of... » read more

polly written 4 months ago

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s... » read more

polly written 5 months ago

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

TOKYO, Jan 11, 2023 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due... » read more

polly written 5 months ago

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

TOKYO, Nov 30, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s... » read more

polly written 6 months ago

Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

polly written 6 months ago

Eisai to Present Full Findings from Lecanemab Confirmatory Phase 3 Clinical Trial (Clarity AD) and Other Alzheimer’s Disease Research at The 15th Clinical Trials on Alzheimer’s Disease (CTAD) Conference

TOKYO, Nov 21, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. will present the efficacy, safety and biomarker findings from the company’s Phase 3 confirmatory Clarity AD clinical trial for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the potential treatment of mild cognitive impairment (MCI) due to Alzheimer’s... » read more

polly written 7 months ago

Eisai’s Lecanemab Confirmatory Phase 3 Clarity AD Study Met Primary Endpoint

TOKYO, Sep 28, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to... » read more

polly written 8 months ago

Eisai Presents New Findings on Lecanemab’s Investigational Subcutaneous Formulation and Modeling Simulation of ApoE4 Genotype on Aria-E Incidence at AAIC 2022

TOKYO and CAMBRIDGE, Mass., Aug 4, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented new findings on a subcutaneous formulation of lecanemab (BAN2401) and the modeling simulation of the impact of ApoE4 genotype on the incidence of amyloid-related imaging abnormalities – edema/effusion (ARIA-E) – in subjects... » read more

polly written 10 months ago

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

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... » read more

polly written 12 months ago

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

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... » read more

polly written 1 year ago

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

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... » read more

polly written 1 year ago

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

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... » read more

polly written 1 year ago

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

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... » read more

polly written 1 year ago

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

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... » read more

polly written 2 years ago

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

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... » read more

polly written 2 years ago

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

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... » read more

polly written 2 years ago

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

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... » read more

polly written 2 years ago

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

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... » read more

polly written 2 years ago

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

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... » read more

polly written 2 years ago