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Jan 6, 2023

FDA Approves LEQEMBI™ (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease

Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI™ Treatment with LEQEMBI should be initiated in patients with...
Dec 19, 2022

EISAI TO DIVEST RIGHTS FOR ANTI-EPILEPTIC DRUG FYCOMPA® (perampanel) CIII IN UNITED STATES TO CATALYST PHARMACEUTICALS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into an agreement to transfer the United States (U.S.) commercial rights for the...
Nov 29, 2022

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

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")...
Nov 29, 2022

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

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")...
Nov 20, 2022

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

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") will present the efficacy, safety and biomarker findings from the company's Phase 3 confirmatory Clarity AD clinical trial for...
Sep 27, 2022

Lecanemab Confirmatory Phase 3 CLARITY AD Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction Of Clinical Decline In Large Global Clinical Study Of 1,795 Participants With Early Alzheimer's Disease

ALL KEY SECONDARY ENDPOINTS ALSO MET, DEMONSTRATING HIGHLY STATISTICALLY SIGNIFICANT RESULTS PROFILE OF AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA) INCIDENCE WAS WITHIN EXPECTATIONS EISAI AIMS TO...
Aug 23, 2022

C2N and Eisai Collaborate to Build Awareness and Real-World Evidence for Blood-Based Assays for Cognitive Impairment in Clinical Practice Outside of Clinical Trial Settings

C2N Diagnostics and Eisai Inc. today announced the Companies have entered into a memorandum of understanding that will seek to build awareness about how blood-based assays for cognitive...
Aug 3, 2022

Eisai Presents New Findings On Lecanemab's Investigational Subcutaneous Formulation And Modeling Simulation Of APOE4 Genotype On ARIA-E Incidence At The Alzheimer's Association International Conference (AAIC) 2022

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced that...
Jul 25, 2022

Eisai To Present The Latest Lecanemab Data, Including ARIA-E And Subcutaneous Formulation, And Other Alzheimer's Disease Research At The Alzheimer's Association International Conference (AAIC) 2022

Eisai Co. Ltd (Headquarters: Toyoko, CEO: Haruo Naito, "Eisai") announced today that the company will present research from its Alzheimer's disease (AD) pipeline, including new data for lecanemab...
Jul 25, 2022

AB-related Paper Published in the American Scientific Journal Science

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that lecanemab, an anti-amyloid-β protofibril antibody being developed by Eisai, has no connection regarding...
Jul 5, 2022

The U.S. FDA Accepts and Grants Priority Review for Eisai's Biologics License Application of Lecanemab for Early Alzheimer's Disease Under the Accelerated Approval Pathway

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Jun 21, 2022

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

Second Publication on the Potential Value of Lecanemab in Patients with Early Alzheimer's Disease Using Simulation Modeling

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its...
Jun 2, 2022

Eisai to Present Latest Data on LEMBOREXANT at the 36th Annual Sleep 2022 Meeting

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today a total of seven poster presentations including the latest data on its in-house discovered orexin receptor...
May 9, 2022

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

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Apr 26, 2022

Long-term Health Outcomes Using Simulation Model of Investigational Lecanemab in Patients with Early Alzheimer's Disease Published in a Peer-Reviewed Journal, Neurology and Therapy

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced an article about long-term health outcomes of its investigational anti-amyloid-beta (Aβ) protofibril antibody...
Apr 7, 2022

Eisai Statement on The Centers For Medicare And Medicaid Services’ National Coverage Determination with Coverage with Evidence Development for Monoclonal Antibodies Directed Against Amyloid for the Treatment Of Alzheimer’s Disease

Eisai stands with people living with Alzheimer’s disease (AD), health care professionals and other members of our AD community. We respect that the Centers for Medicare and Medicaid Services...
Apr 4, 2022

Geisinger, Eisai team up to study use of artificial intelligence for early detection and identification of cognitive impairment that could indicate dementias, including Alzheimer's disease

Research collaboration will test novel algorithm's effectiveness on Geisinger data DANVILLE, Pa. and NUTLEY, N.J., April 4, 2022 /PRNewswire/ -- Geisinger and Eisai Inc. today announced a...
Mar 31, 2022

Eisai to Present Data on Neurology Portfolio in the Areas of Alzheimer's Disease, Sleep and Epilepsy at the 74th American Academy of Neurology® (AAN) Annual Meeting

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today the company will present research from its robust neurology portfolio, including the findings on lecanemab, an...
Mar 22, 2022

Sysmex Presents Academic Report in Effort to Create a Simple Blood Test to Diagnose Alzheimer's Disease

The Content Presented at the International Conference on Alzheimer's & Parkinson's Diseases: (AD/PD™ 2022) KOBE, Japan and TOKYO, March 22, 2022 /PRNewswire/ -- Sysmex Corporation (Chairman and CEO:
Mar 21, 2022

Latest Findings on Lecanemab - Clinical Efficacy, ARIA Rates, Biomarkers Relationship to Clinical Outcomes and Dosing Regimens - Presented At AD/PD™ 2022 Annual Meeting

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Mar 14, 2022

Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments

Aducanumab collaboration to convert from Eisai sharing of global profits and losses to a global royalty arrangement, effective January 1, 2023. Lecanemab collaboration to continue unchanged globally. Lecanemab supply agreement to extend to 10 years from 5 years for commercial manufacturing by Biogen. Both companies will continue to collaborate together with the goal of bringing more options to patients and maximizing the value of both products

CAMBRIDGE, Mass., and TOKYO, March 14, 2022: Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced today that the companies have amended their existing collaboration agreement on...
Mar 10, 2022

Eisai To Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State Symposium, and Other Pipeline Assets at the AD/PD™ 2022 Annual Meeting

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today the company will present research from its robust Alzheimer's disease (AD) pipeline, including the latest findings...
Mar 3, 2022

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

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Feb 9, 2022

Eisai Submits Formal Comments to the Centers for Medicare and Medicaid Services’ Proposed National Coverage Determination with Coverage with Evidence Development for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai“) announced today that, as part of the public comment period, its U.S. subsidiary, Eisai Inc., has submitted formal comments...
Jan 27, 2022

Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM®

Cambridge, Mass. – January 27, 2022– Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study,...
Jan 18, 2022

First Subject Enrolled in Phase II/III Study of Eisai's Anti-MTBR Tau Antibody E2814 for Dominantly Inherited Alzheimer's Disease (DIAD), Conducted by DIAN-TU

EISAI'S ANTI-AMYLOID BETA PROTOFIBRIL ANTIBODY LECANEMAB SELECTED AS THE BACKGROUND THERAPY FOR THE TAU NEXGEN STUDY

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of...
Jan 13, 2022

Eisai’s Statement on the Draft National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

As always, our thoughts are with the people living with Alzheimer’s disease and their families, and we understand how devastating the proposed National Coverage Determination (NCD) from the...
Dec 23, 2021

Investigational Alzheimer's Disease Therapy Lecanemab Granted FDA Fast Track Designation

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Dec 20, 2021

Biogen Announces Reduced Price for ADUHELM® to Improve Access for Patients With Early Alzheimer’s Disease in the United States

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that, effective January 1, 2022, Biogen will reduce the wholesale acquisition cost (WAC) of ADUHELM®...
Dec 7, 2021

Eisai Presents Its Largest Real-World Study Of Anti-Epileptic Drug FYCOMPA® (perampanel) Across Patient Types At The 2021 American Epilepsy Society (AES) Annual Meeting

Eisai Inc. presented data from PERMIT, a large real-world clinical study evaluating its antiepileptic drug (AED) FYCOMPA® (perampanel) CIII, including as monotherapy and early add-on therapy for...
Dec 7, 2021

Eisai Presents Final Results Of Phase IV Elevate Study Of Anti-Epileptic Drug FYCOMPA® (perampanel) At The American Epilepsy Society (AES) 2021 Annual Meeting

Eisai Inc. presented analyses of the ELEVATE study of its antiepileptic drug (AED) FYCOMPA® (perampanel) CIII at the 2021 American Epilepsy Society (AES) Annual Meeting. ELEVATE was a...
Dec 1, 2021

Eisai To Present Real-World Evidence And Convulsive Seizure Freedom Data Evaluating FYCOMPA® (perampanel) Across Patient Types At 75th American Epilepsy Society (AES) Annual Meeting

EMBARGOED UNTIL: 9:00 AM CT on December 3

Eisai Inc. announced today that new data on its antiepileptic drug FYCOMPA® (perampanel) CIII will be presented at the 75th American Epilepsy Society (AES) Annual Meeting to be held from December...
Nov 22, 2021

Statement on JAMA Neurology Publication about Amyloid-Related Imaging Abnormalities in Two Phase 3 Studies Evaluating Aducanumab in Early Alzheimer’s Disease

Today, Biogen and Eisai announced that the Journal of the American Medical Association (JAMA) Neurology published a peer-reviewed paper about findings around amyloid-related imaging abnormalities...
Nov 11, 2021

New Phase 3 Data Show Positive Correlation Between ADUHELM™ Treatment Effect on Biomarkers and Reduction in Clinical Decline in Alzheimer’s Disease

In a pre-specified analysis, ADUHELM significantly lowered plasma p-tau181, a biomarker of the hallmark tau tangles in Alzheimer’s disease, in both Phase 3 trials in a dose- and time-dependent manner vs. placebo

Cambridge, Mass. – November 11, 2021– Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced that data from approximately 7,000 plasma samples from more than 1,800 patients in...
Nov 11, 2021

Introduction of First-Of-A-Kind Plasma-Based Biomarker Screening To Facilitate Identification Of Subjects For Phase 3 Ahead 3-45 Trial Presented At Clinical Trials On Alzheimer's Disease (CTAD) Conference

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced a...
Nov 11, 2021

Eisai Presents New Analysis Of Lecanemab Clinical Efficacy Results From Phase 2b Study At Clinical Trials On Alzheimer's Disease (CTAD) Conference

Consistency of Efficacy Assessments Evaluated Across Various Statistical Methods

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Nov 10, 2021

Eisai Presents Late-Breaker Updates On Lecanemab Clinical, Biomarker And Safety Data From Phase 2b Study Core And Open-Label Extension Across Five Years At Clinical Trials On Alzheimer's Disease (CTAD) Conference

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Nov 8, 2021

DIAN-TU Selects Lecanemab As Background Anti-Amyloid Therapy In Clinical Trial Evaluating Investigational Therapy Targeting Tau For Dominantly Inherited Alzheimer's Disease

Eisai's anti-microtubule binding region (MTBR) tau antibody E2814 previously selected as the first investigational therapy among anti-tau drugs for the DIAN-TU Tau Next Generation trial

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of...
Nov 4, 2021

Eisai Presents New Data on the Relationship between Clinical, Biomarker and Safety Outcomes from the Lecanemab Phase 2b Study for Early Alzheimer's disease in Late-Breakers and Pipeline Updates at the Clinical Trials on Alzheimer's Disease (CTAD) Conference

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today the presentation of data from the company's extensive Alzheimer's disease (AD) pipeline, including six oral...
Sep 27, 2021

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

Lecanemab Is An Anti-Amyloid Beta (Aβ) Protofibril Antibody

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced...
Jul 29, 2021

Late-Breaking AAIC Presentation Explores Potential Clinical Effects Of Lecanemab (BAN2401)

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer's Association International Conference (AAIC)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced...
Jul 29, 2021

Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021

• ICARE AD-US is an observational real-world phase 4 study designed to evaluate the safety and effectiveness of ADUHELM in clinical practice

CAMBRIDGE, Mass., July 29, 2021 – Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced that Biogen will lead a late-breaking presentation on the design of the first real-world...
Jul 26, 2021

Biogen and Eisai Announce ADUHELMTM (aducanumab-avwa) Data Presentations at Alzheimer’s Association International Conference 2021

Item-level analysis from EMERGE trial shows consistency in slowing decline across cognitive, functional and behavioral measures in early Alzheimer’s disease

CAMBRIDGE, Mass., July 26, 2021 -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen, as part of its Alzheimer’s disease (AD) research portfolio, will...
Jul 22, 2021

Eisai Alzheimer's Disease Pipeline Research, Including New Lecanemab (BAN2401) Data, to be Presented at 2021 Alzheimer's Association International Conference (AAIC)

- Lecanemab Late-Breaker: Oral Presentation of Preliminary Assessment of Lecanemab's Clinical Effects from Open Label Extension Phase 2 Proof of Concept Study in Subjects with Early Alzheimer's Disease

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today the presentation of findings from the company's robust Alzheimer's disease (AD) pipeline, including lecanemab...
Jul 8, 2021

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

CAMBRIDGE, Mass. and TOKYO, JULY 8, 2021 (GLOBE NEWSWIRE) – Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced the U.S. Food and Drug Administration (FDA) has approved an...
Jun 23, 2021

Eisai And Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation For Lecanemab (BAN2401), An Anti-Amyloid Beta Protofibril Antibody For The Treatment Of Alzheimer's Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced...
Jun 23, 2021

Biogen and Eisai Update for the Alzheimer’s Disease Community

CAMBRIDGE, Mass. and WOODCLIFF LAKE, N.J., June 23, 2021 – Biogen (Nasdaq: BIIB) and Eisai Inc., U.S. subsidiary of Eisai Co., Ltd. today issued the following statement: On June 7, 2021,...
Jun 9, 2021

Eisai to Present Latest DAYVIGO® (lemborexant) CIV Data at 35th Annual Virtual SLEEP 2021 Meeting

Presentations featuring data evaluating DAYVIGO in insomnia highlighting the impact for appropriate patients

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today new presentations featuring the latest data about the company's insomnia medication DAYVIGO (lemborexant) will be...
Jun 7, 2021

Biogen and Eisai launch multiple initiatives to help patients with Alzheimer’s disease access ADUHELM™

Programs now available to support patients and families with their treatment journey

CAMBRIDGE, Mass. and WOODCLIFF LAKE, N.J., June 07, 2021 (GLOBE NEWSWIRE) -- Following today’s U.S. Food and Drug Administration’s (FDA) accelerated approval of ADUHELMTM (aducanumab-avwa) as...
Jun 7, 2021

FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease

The accumulation of amyloid beta plaques in the brain is a defining pathology of Alzheimer’s disease

CAMBRIDGE, Mass. and TOKYO, June 7, 2021 (GLOBE NEWSWIRE) – Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted...

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