OTC:ESALF

Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

Retrieved on: 
Tuesday, December 19, 2023

TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.

Key Points: 
  • TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.
  • In Japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, (MHLW).
  • This application is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 201) in Japan and China conducted by Eisai.
  • Study 201 enrolled patients with unresectable biliary tract cancer with FGFR2 gene fusion previously treated with gemcitabine-based combination chemotherapy.

Eisai and Mizuho Sign Sustainability-Linked Loan Agreement

Retrieved on: 
Thursday, December 14, 2023

TOKYO, Dec 14, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Mizuho Bank, Ltd. announced today that the companies have signed a sustainability-linked syndicated loan agreement, which comes into effect today.

Key Points: 
  • TOKYO, Dec 14, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Mizuho Bank, Ltd. announced today that the companies have signed a sustainability-linked syndicated loan agreement, which comes into effect today.
  • Under the concept of human health care (hhc), Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities.
  • With the funds raised through this agreement, Eisai will promote the creation of social impact through the elimination of diseases of poverty (neglected tropical diseases, malaria, tuberculosis, etc.
  • This agreement has undergone a third-party review* by Rating and Investment Information, Inc. (R&I) regarding its compliance with the Sustainability-Linked Loan Principles issued by the Loan Market Association and other organizations, as well as the Green Loan and Sustainability-Linked Loan Guidelines issued by Japan's Ministry of the Environment.

"LEQEMBI Intravenous Infusion"Lecanemab) for the Treatment of Alzheimer's Disease to be Launched in Japan on December 20

Retrieved on: 
Thursday, December 14, 2023

The launch in Japan marks the second country to have LEQEMBI on the market, following the U.S.

Key Points: 
  • The launch in Japan marks the second country to have LEQEMBI on the market, following the U.S.
  • In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.
  • In consideration of the importance of Alzheimer's disease in Japan, we believe it is imperative that such pathways be established.
  • We are committed to taking this first step towards changing the future of Alzheimer's disease together with our stakeholders."

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-001 Trial Evaluating LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
Monday, December 11, 2023

The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination.

Key Points: 
  • The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination.
  • We are grateful to the patients, their loved ones, and the investigators whose participation is what makes scientific advancement possible."
  • LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of certain types of advanced endometrial carcinoma following prior systemic therapy in any setting and advanced renal cell carcinoma (RCC).
  • Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

Eisai's Sales Subsidiary Collaborates with Ministry of Public Health (MOPH) in Thailand

Retrieved on: 
Thursday, November 30, 2023

TOKYO, Nov 30, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co., Ltd., (Eisai Thailand) has made an agreement to collaborate with the Department of Medical Services (DMS), Ministry of Public Health (MOPH) of Thailand to further enhance the access to treatments for dementia including Alzheimer's disease (AD) in Thailand.

Key Points: 
  • TOKYO, Nov 30, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co., Ltd., (Eisai Thailand) has made an agreement to collaborate with the Department of Medical Services (DMS), Ministry of Public Health (MOPH) of Thailand to further enhance the access to treatments for dementia including Alzheimer's disease (AD) in Thailand.
  • In Thailand, the number of people suffering from dementia is expected to increase significantly from the current 700 thousand to 2 million by 2050 due to the rapid aging of the population.
  • Formulation of disease guidelines by the state is essential to address these challenges.
  • Eisai Thailand and DMS will jointly conduct surveys and other initiatives to establish such guidelines.

Eisai to Present Latest Data on Perampanel at The 77th American Epilepsy Society (AES) Annual Meeting

Retrieved on: 
Wednesday, November 22, 2023

Major presentations include the design and outcomes of a clinical research evaluating the safety of perampanel versus placebo (Poster No.

Key Points: 
  • Major presentations include the design and outcomes of a clinical research evaluating the safety of perampanel versus placebo (Poster No.
  • 1.493), and the data of evaluating the effects of perampanel on cognitive function and sleep (Poster No.
  • Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.

LEQEMBI Wins Best New Drug And Clinical Advance of The Year at The Scrip Awards 2023

Retrieved on: 
Monday, November 20, 2023

The Scrip Awards, now in its 19th year, celebrates the best innovations and achievements of the international biopharma industry.

Key Points: 
  • The Scrip Awards, now in its 19th year, celebrates the best innovations and achievements of the international biopharma industry.
  • The award for Clinical Advance of the Year recognizes the success of a new drug product in a clinical trial that is expected to lead to an advance in healthcare.
  • It was awarded for the success of the Phase III Clarity AD study of LEQEMBI.
  • Eisai and Biogen deeply appreciate the cooperation of people living with AD and healthcare professionals who participated in LEQEMBI's clinical studies.

LEQEMBI (lecanemab-Irmb) Named One of Time's Best Inventions of 2023

Retrieved on: 
Wednesday, October 25, 2023

TOKYO, Oct 25, 2023 - (JCN Newswire) - Eisai Co. Ltd. announced today that TIME has selected Alzheimer's disease (AD) treatment LEQEMBI (lecanemab-irmb) as one of THE BEST INVENTIONS of 2023 in the Medical Care category.

Key Points: 
  • TOKYO, Oct 25, 2023 - (JCN Newswire) - Eisai Co. Ltd. announced today that TIME has selected Alzheimer's disease (AD) treatment LEQEMBI (lecanemab-irmb) as one of THE BEST INVENTIONS of 2023 in the Medical Care category.
  • TIME's annual list of THE BEST INVENTIONS features "200 extraordinary innovations changing lives."
  • TIME then evaluated each contender on a number of key factors, including originality, efficacy, ambition, and impact.
  • We will deliver LEQEMBI to the people with early AD who need it and their families, and aim to continue creating impact on global issues surrounding dementia.

Eisai to Present New Data from LEQEMBI (Lecanemab-Irmb) Phase 3 Clarity Ad Study and Other Alzheimer's Disease Pipeline Research at The Clinical Trials on Alzheimer's Disease (CTAD) Conference

Retrieved on: 
Monday, October 16, 2023

The conference will be held in Boston, Massachusetts, United States and virtually from October 24 to 27, 2023.

Key Points: 
  • The conference will be held in Boston, Massachusetts, United States and virtually from October 24 to 27, 2023.
  • At the conference, Eisai will present data and research in five oral and ten poster presentations.
  • "We look forward to sharing the new LEQEMBI low-tau subgroup data and subcutaneous data at CTAD 2023."
  • The full list of presentations about Eisai assets and research, click the link: www.eisai.com/news/2023/news202365.html