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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 New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

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
Acquisition, D&I, DE, Ministry of Health, FY, D, Armourers and Brasiers' Company Prize, Ministry of Health, Labour and Welfare, Empowerment, NPO, Organization, Ministry, Diversity, Female, Patient, Accreditation, Basic category, Ministry of Economy, Trade and Industry, Equity, Knowledge, The Excellence in Diversity Awards, Eisai, Collaborative innovation network, R, Auction, Nursing, Health

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
Health, Organization, Ministry, Certified Health Executive, Patient, Woman, Ministry of Economy, Trade and Industry, COVID-19, Product manager, Infection, White, Mental health, Eisai, Management

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 New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

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.