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 […]
TOKYO, Jan 9, 2023 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the conversion of the Accelerated Approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval. This […]
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 […]
TOKYO, Nov 4, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co. Ltd. (“Eisai Thailand”) made an agreement to collaborate in supporting access to treatments for dementia, including Alzheimer’s disease, in Thailand with Thai Life Insurance Public Company Limited, a leading life insurance […]
TOKYO, Jul 26, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co. Ltd announced today that the company will present research from its Alzheimer’s disease (AD) pipeline, including new data for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild […]
TOKYO, Jul 6, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild […]
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 […]
TOKYO, Mar 11, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today the company will present research from its robust Alzheimer’s disease (AD) pipeline, including the latest findings on lecanemab, Eisai’s investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early AD at the AD/PD 2022 International Conference on Alzheimer’s and […]
TOKYO, Jan 19, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled the first subject in the phase II/III study (Tau NexGen study). The study will assess the effect of Eisai’s […]
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 […]
TOKYO, Nov 12, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen Inc. and Eisai Co., Ltd. (Tokyo, Japan) announced that data from approximately 7,000 plasma samples from more than 1,800 patients in the ADUHELM (aducanumab-avwa) Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in […]
TOKYO, Nov 9, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has an agreement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to amend the clinical […]
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 […]
TOKYO, Jul 30, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer’s disease called ICARE AD-US, at the Alzheimer’s Association International Conference (AAIC), being held both virtually and […]
TOKYO, Jul 27, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen, as part of its Alzheimer’s disease (AD) research portfolio, will contribute four virtual posters that showcase data from its clinical trials with ADUHELM (aducanumab-avwa) injection 100 mg/mL solution at the Alzheimer’s Association […]
TOKYO, Jul 21, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that the company will conduct a total of 11 presentations, including the latest data of the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (development code: BAN2401) for which the U.S. Food and Drug Administration has granted Breakthrough Therapy designation, at […]
Cambridge, MA, Jun 8, 2021 – (JCN Newswire via SEAPRWire.com) – Following U.S. Food and Drug Administration’s (FDA) accelerated approval of ADUHELMTM (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain, Biogen (Nasdaq: BIIB) and Eisai Inc., U.S. subsidiary […]
TOKYO, Jun 8, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for ADUHELM (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid […]
TOKYO, Apr 23, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that Biogen (Nasdaq: BIIB) has disclosed, in its Q1 2021 Earnings Press Release issued on April 22, its current submission status of the Marketing Authorization Applications (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease, in countries other than the […]
TOKYO, Apr 20, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-Abeta Protofibril Antibody, in the peer-reviewed journal Alzheimer’s Research and Therapy. The manuscript describes results […]