Eisai

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

Eisai Receives the "Basic Achievement Grand Prize" at the 2023 J-Win Diversity Award

Retrieved on: 
Friday, March 10, 2023

TOKYO, Mar 10, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it was selected as the winner of the "Basic Achievement Grand Prize" at the "2023 J-Win Diversity Award" held by non-profit organization Japan Women's Innovative Network (NPO J-Win).

Key Points: 
  • TOKYO, Mar 10, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it was selected as the winner of the "Basic Achievement Grand Prize" at the "2023 J-Win Diversity Award" held by non-profit organization Japan Women's Innovative Network (NPO J-Win).
  • The "J-Win Diversity Award" has been held annually since 2008 with the aim of accelerating the promotion of diversity and inclusion (D&I) in Japanese companies by awarding leading businesses that are promoting D&I.
  • - Plans to introduce a new personnel assessment system from FY 2023, which utilizes a behavioral assessment item "Diversity & Synergy" to further focus on diversity.
  • Eisai aims to realize the spiral of knowledge generated by diversity, regardless of differences in nationality, gender, age, etc., leading to the creation of innovation.

Eisai Certified as a 2023 Health and Productivity Management Outstanding

Retrieved on: 
Thursday, March 9, 2023

TOKYO, Mar 9, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has been certified as a Health and Productivity Management Outstanding Organization in the large enterprise category (White 500) by Japan's Ministry of Economy, Trade and Industry and the Nippon Kenko Kaigi.

Key Points: 
  • TOKYO, Mar 9, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has been certified as a Health and Productivity Management Outstanding Organization in the large enterprise category (White 500) by Japan's Ministry of Economy, Trade and Industry and the Nippon Kenko Kaigi.
  • It recognizes outstanding enterprises engaging in efforts for health and productivity management by evaluating from a business-management perspective based on the following criteria: "management philosophy and policies", "organized frameworks", "systems and implementation of measures", and "evaluation and improvement".
  • Eisai issued the "Eisai Health Declaration" in 2019, and has strategically implemented health management for employees from a management perspective.
  • Eisai will continue to promote health and productivity management to increase non-financial value and further contribute to increasing the benefits of patients and the people in the daily living domain.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Biogen Japan and Eisai Provide Update on Co-Promotion Of Multiple Sclerosis Treatments In Japan

Retrieved on: 
Thursday, March 2, 2023

The two companies have been jointly engaged in promotional activities for MS treatments in Japan.

Key Points: 
  • The two companies have been jointly engaged in promotional activities for MS treatments in Japan.
  • As a result, Biogen Japan will have full responsibility for all operations related to the products after a transition period between the two companies.
  • Upon termination of this agreement, Biogen will pay Eisai 31 million USD.
  • The termination of this co-promotion agreement does not impact any of the other agreements between Biogen and Eisai.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Tuesday, February 28, 2023

TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Key Points: 
  • TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Monday, February 27, 2023

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.

Key Points: 
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Dissolution of Bracco-Eisai Joint Venture

Retrieved on: 
Tuesday, February 21, 2023

TOKYO, Feb 21, 2023 - (JCN Newswire) - Bracco Imaging S.p.A. and Eisai Co., Ltd. announced today that the joint venture regarding the company Bracco-Eisai Co., Ltd. (Ratio of Shares Held: Bracco 51% Eisai 49%), will be dissolved as of March 31, 2023.

Key Points: 
  • TOKYO, Feb 21, 2023 - (JCN Newswire) - Bracco Imaging S.p.A. and Eisai Co., Ltd. announced today that the joint venture regarding the company Bracco-Eisai Co., Ltd. (Ratio of Shares Held: Bracco 51% Eisai 49%), will be dissolved as of March 31, 2023.
  • As a result, Bracco will acquire all shares of Bracco-Eisai held by Eisai and change its name from Bracco-Eisai to Bracco Japan, Co., Ltd. as of April 1, 2023.
  • Bracco and Eisai established Bracco-Eisai in 1990 with the aim of establishing a contrast agent business in Japan.
  • After comprehensive consideration, the companies decided to dissolve the joint venture in order to respond quickly and flexibly to the changing environment surrounding the healthcare industry and achieve sustainable contributions to patients through these products.

Haymarket Medical Education’s Insomnia Working Group Publishes Updated Recommendations for Managing Insomnia Disorder in Primary Care in Primary Care Companion for CNS Disorders (Psychiatrist.com)

Retrieved on: 
Monday, January 23, 2023

“A 2023 Update on Managing Insomnia in Primary Care: Insights From an Expert Consensus Group” is the outcome of the March 2022 meeting of The Insomnia Working Group, a consensus panel of insomnia experts in primary care, psychiatry, and clinical research, that included a patient with insomnia.

Key Points: 
  • “A 2023 Update on Managing Insomnia in Primary Care: Insights From an Expert Consensus Group” is the outcome of the March 2022 meeting of The Insomnia Working Group, a consensus panel of insomnia experts in primary care, psychiatry, and clinical research, that included a patient with insomnia.
  • The panel convened to identify gaps in the recognition, diagnosis, and management of insomnia in primary care and to review new data on available and emerging insomnia treatments.
  • The January 24th article details evidence that treating insomnia disorder can result in improvements in comorbid illness and quality of life.
  • Panel members recommend that primary care clinicians proactively screen for evidence of insomnia, especially in patients presenting with medical or psychiatric illnesses.

European Medicines Agency accepts Marketing Authorization Application for lecanemab as treatment for early Alzheimer's disease: BioArctic

Retrieved on: 
Friday, January 27, 2023

In conjunction with EMA's acceptance of the file, BioArctic is entitled to a milestone of MEUR 5.

Key Points: 
  • In conjunction with EMA's acceptance of the file, BioArctic is entitled to a milestone of MEUR 5.
  • In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • BioArctic has right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.