Frankfurt:EII

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Monday, January 30, 2023
Disease, The New England Journal of Medicine, Alzheimer's disease, European Medicines Agency, PMDA, National Medical Products Administration, Amyloid beta, Priority review, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MHLW, FDA, AD, Medication, Marketing, Pharmaceuticals and Medical Devices Agency, Food, Neurotoxicity, Medicines and Healthcare products Regulatory Agency, Eisai, BLA, Co-promotion, NMPA, Clarity, Phase, MAA, EMA, Pharmaceutical industry, Health, Biogen

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 Abeta 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.

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

Retrieved on: 
Friday, January 27, 2023
Free agent, Brain, European Medicines Agency, PMDA, National Medical Products Administration, Amyloid beta, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, PMID, Medication, Pharmaceuticals and Medical Devices Agency, Food, Medicines and Healthcare products Regulatory Agency, BLA, Eisai, PLOS One, Co-promotion, NMPA, Phase, Alzheimer's disease, MAA, EMA, 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.
  • On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study.
  • 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 Commences Business Activities at New Pharma Sales Subsidiary in Israel

Retrieved on: 
Thursday, January 19, 2023
Marketing, Patient, Lenvatinib, Pharmaceutical industry, Eisai

TOKYO, Jan 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that fully-fledged operations and business activities have begun at Eisai Israel Ltd., a pharmaceutical sales subsidiary recently established in Tel Aviv in the State of Israel (Israel).

Key Points: 
  • TOKYO, Jan 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that fully-fledged operations and business activities have begun at Eisai Israel Ltd., a pharmaceutical sales subsidiary recently established in Tel Aviv in the State of Israel (Israel).
  • In 2011, Eisai Europe started business in Israel marketing and selling Eisai products through local distribution partners, and mainly marketed Lenvima, Halaven, Fycompa and Inovelon.
  • Eisai Israel was established in August 2021, and in January 2023, became the marketing authorization holder of the Eisai products in Israel.
  • With the commencement of operations at Eisai Israel, Eisai aims to utilize its own drug sales system in Israel, deliver innovative new drugs to more patients in Israel as quickly as possible, and contribute to improving the benefits of patients and their families.

Eisai Listed as a Global 100 Most Sustainable Corporation for The Seventh Time Highest Ranked Global Pharmaceutical Company

Retrieved on: 
Thursday, January 19, 2023
Eisai, Patient, ESG, Environment, Corporate Knights, Pharmaceutical industry

TOKYO, Jan 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced that it has been listed in the 2023 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc.

Key Points: 
  • TOKYO, Jan 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced that it has been listed in the 2023 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc.
  • Ranked 53rd, Eisai was the highest ranking company among global pharmaceutical companies (please visit here(New Window) for the Global 100 ranking).
  • The Global 100 evaluates the sustainability of more than 6,000 of the world's major corporations based on various corporate initiatives in areas such as ESG (environment, society and governance).
  • Since 2005, those companies ranking among the top 100 in the world have been announced each year.

Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023

Retrieved on: 
Wednesday, January 18, 2023
MSD, Headquarters, TRADD, PRISM, Nivolumab, ASCO, Esophageal cancer, Stomach, Colorectal cancer, Pharmacokinetics, Safety, FDA, CBP, American Society of Clinical Oncology, Senior, Research, Gastrointestinal cancer, CREB-binding protein, Eisai, Patient, Merck Sharp & Dohme Federal Credit Union, Merck & Co., Society, LEAP, Medical imaging, Pharmaceutical industry, Merck

Based on these additional analyses, further investigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing using two dose levels in the expansion part.

Key Points: 
  • Based on these additional analyses, further investigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing using two dose levels in the expansion part.
  • Additional presentations on Eisai's oncology pipeline showcase Eisai's investigational compound, E7389- LF, a new liposomal formulation of eribulin, in combination with nivolumab in patients with solid tumors.
  • Efficacy and safety were evaluated in expansion cohorts, including an esophageal cancer cohort (NCT04078295; Abstract: #337) and a gastric cancer cohort (NCT04078295; Abstract: #339).
  • To date, more than 10 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan

Retrieved on: 
Monday, January 16, 2023
PET, Brain, Brand, European Medicines Agency, PMDA, Headache, National Medical Products Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, FDA, Superficial siderosis, AD, Siderosis, Medication, Pharmaceuticals and Medical Devices Agency, Food, Medicines and Healthcare products Regulatory Agency, BLA, Eisai, Co-promotion, NMPA, MCI, Clarity, ADCS, Phase, Alzheimer's disease, EMA, MAA, Medical imaging, Medical device, Pharmaceutical industry, Biogen

Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.

Key Points: 
  • Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.
  • On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.
  • In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023.
  • 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.

Eisai Launches Renewed Sustainability Page

Retrieved on: 
Friday, January 13, 2023
Anxiety, Eisai, Patient, Environment, Health, Sustainability, Marketing

TOKYO, Jan 13, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced that it has renewed the Sustainability page of its corporate website and it is now accessible to the public.

Key Points: 
  • TOKYO, Jan 13, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced that it has renewed the Sustainability page of its corporate website and it is now accessible to the public.
  • Therefore, it is extremely important for our company to contribute to the sustainability of society by actively addressing global environmental and social issues.
  • In order to provide information about our sustainability approach and activities in an easy-to-understand manner, we have enhanced the content, and renewed the key visuals, design and page structure.
  • Through further efforts in our proactive disclosure of information for sustainability, we will aim to develop and maintain favorable relations with all of our stakeholders.