EISAI


Associated tags: Health, Anxiety, Patient, Neurology, Eisai, Pharmaceutical industry

Locations: NEW JERSEY, CANADA, ASIA, TAIWAN, HONG KONG, AFRICA, CAMBRIDGE, CHICAGO, MA, US, ILLINOIS, SAN FRANCISCO, CALIFORNIA, NORTH AMERICA, SPAIN, NJ, USA, MACAU, AD

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.

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

Retrieved on: 
Thursday, March 2, 2023
Eisai, Biogen, MS, Dimethyl fumarate, Natalizumab, Pharmaceutical industry

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
Amyloid beta, Ministry of Health, Labour and Welfare, Lecanemab, Alzheimer's disease, Ministry, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, Brain, Research, The New England Journal of Medicine, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

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
Ministry of Health, Labour and Welfare, Lecanemab, Ministry, BIIB, Corporation, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, The New England Journal of Medicine, Brain, Research, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Headquarters, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

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
Partnership, System Technology-i Co, Ltd, MRI, Patient, Google Images, Iomeprol, Environment, Gadoteridol, Medical imaging, Eisai

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.

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Sunday, January 29, 2023
Medicines and Healthcare products Regulatory Agency, Marketing, Disease, MAA, NMPA, Food, Neurotoxicity, Clarity, Pharmaceuticals and Medical Devices Agency, Headquarters, Corporation, National Medical Products Administration, European Medicines Agency, Medication, MHLW, Phase, BLA, Co-promotion, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, BIIB, AD, The New England Journal of Medicine, Eisai, EMA, PMDA, Priority review, Pharmaceutical industry, Biogen, Health

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

Key Points: 
  • Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
  • In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency

Retrieved on: 
Thursday, January 26, 2023
Medicines and Healthcare products Regulatory Agency, Brand, MAA, NMPA, Food, Pharmaceuticals and Medical Devices Agency, Headquarters, Corporation, National Medical Products Administration, European Medicines Agency, Medication, Phase, BLA, Co-promotion, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, BIIB, AD, Eisai, EMA, PMDA, Pharmaceutical industry, Biogen

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.

Key Points: 
  • 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.
  • In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.