Eisai

Eisai to Present the Latest Alzheimer's Disease Pipeline and Research

Retrieved on: 
Wednesday, July 12, 2023
Washington University in St. Louis, Senior, Disease, Amyloid beta, Alzheimer's Disease Neuroimaging Initiative, Pharmacokinetics, Research, Biomarker, MCI, Lecanemab, Downstream, AAIC, Patient, Clinical research, AIC, Poster, AD, Conference, Safety, Pharmaceutical industry, Alzheimer's disease, Domination, Eisai

The conference will be held in Amsterdam, the Netherlands and virtually from July 16 to 20, 2023.

Key Points: 
  • The conference will be held in Amsterdam, the Netherlands and virtually from July 16 to 20, 2023.
  • Eisai will present data and research in eight oral and 19 poster presentations at the meeting.
  • Two of the AAIC oral presentations will be presented as posters at the Alzheimer's Disease Imaging Consortium (AIC), which will be held at the same venue as AAIC on July 15.
  • "At AAIC 2023 Eisai will present the latest data on lecanemab, an anti-Aβ protofibril antibody, that recently received traditional approval in the U.S. for patients with mild cognitive impairment (MCI) due to AD and mild AD.

Eisai: FDA Grants Traditional Approval for LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Friday, July 7, 2023
Amyloid-related imaging abnormalities, Insurance, Disease, CMS, Clinical trial, PCNS, The New England Journal of Medicine, Deficit spending, Research, Today, MCI, Neurotoxicity, Committee, Medicare, Clarity, ARIA, HIV disease progression rates, Patient, Immunoglobulin G, Co-promotion, Diagnosis, Lecanemab, AD, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, ADCS, Conditional sentence, Pharmaceutical industry, Alzheimer's disease, Biogen, Eisai

Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.

Key Points: 
  • Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.
  • LEQEMBI treatment reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.
  • Importantly, following FDA's traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available and released more details on the registry, including the easy-to-use data submission process.
  • "Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer's disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease.

New NEURii Research Collaboration Between Eisai, Gates Ventures, Health Data Research UK, Lifearc and The University of Edinburgh to Develop Digital Solutions for Dementia is Announced

Retrieved on: 
Friday, June 30, 2023
Pressure, Maintenance, LifeArc, Partnership, University, Therapy, Life, Doctor of Philosophy, Speech, Public, Neurodegenerative disease, University of Edinburgh, Health, Ageing, Alzheimer's Research UK, Quality of life, ML, Research, Genomics, Biomarker, Mentorship, HDR, Disorder, Dementia, Alzheimer's disease, Digital technology, HIV disease progression rates, Patient, Orangi Pilot Project, Machine learning, Algorithm, Artificial intelligence, Drug discovery, Gates Ventures, Diagnosis, AI, Neurology, Disease, Pharmaceutical industry, Industrial design, Medical device, Nursing, Eisai

- NEURii collaboration builds on Eisai's extensive experience in delivering innovative treatments in neurology and supports ongoing contributions to the global digital health ecosystem.

Key Points: 
  • - NEURii collaboration builds on Eisai's extensive experience in delivering innovative treatments in neurology and supports ongoing contributions to the global digital health ecosystem.
  • TOKYO, HATFIELD, SEATTLE, LONDON, and EDINBURGH, June 30, 2023 - (JCN Newswire) - Eisai, Gates Ventures, Health Data Research UK (HDR UK), LifeArc and The University of Edinburgh announced today a new two-year collaborative research agreement.
  • NEURii will focus its initial efforts to develop data and digital solutions to complement approved treatment options for patients and solve issues related to the prediction, prevention, management, and treatment of dementia related disorders.
  • It is envisaged that NEURii partners will explore further opportunities to scale up the program developing digital health solutions worldwide.

Eisai's "Nouknow" Will Continue to be Utilized for Brain Health Assessment as Part of The FY2023 Dementia Examination Project by Tokyo Bunkyo City

Retrieved on: 
Thursday, June 22, 2023
Success, Policy, PFS, Dementia, Organization, Eisai, Nursing, Co-promotion, Self-assessment, Diagnosis, Patient, Social, Health, Disease, Residential care

TOKYO, June 22, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that brain health checks utilizing "NouKNOW" (pronounced "NOH-NOH"), Eisai's digital tool for self-assessment of cognitive function, will continue to be promoted as part of the FY2023 dementia examination project, conducted by Bunkyo City, Tokyo.

Key Points: 
  • TOKYO, June 22, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that brain health checks utilizing "NouKNOW" (pronounced "NOH-NOH"), Eisai's digital tool for self-assessment of cognitive function, will continue to be promoted as part of the FY2023 dementia examination project, conducted by Bunkyo City, Tokyo.
  • This project is designed to encourage approximately 12,300 Bunkyo City residents between the ages of 55 and 75, at a milestone of every 5 years, to have a brain health check using "NouKNOW".
  • The dementia examination project has been implemented since FY2021 as a priority policy of Bunkyo City, and Eisai has been providing "NouKNOW" and operational support for their public examinations.
  • In FY2023, Eisai will continue to raise awareness of brain health among residents and contribute to early detection and support of dementia.

Eisai Files Marketing Authorization Application for Lecanemab as Treatment For Early Alzheimer's Disease in South Korea

Retrieved on: 
Thursday, June 8, 2023
Disease, Alzheimer's disease, Ministry of Food and Drug Safety, BIIB, Lecanemab, MFDS, Brain, The Different Forms of Flowers on Plants of the Same Species, Ministry, Clarity, Eisai, Co-promotion, AD, Neurotoxicity, Pharmaceutical industry, Biogen, Food

This application is the first application for lecanemab in Asia outside of Japan and China.

Key Points: 
  • This application is the first application for lecanemab in Asia outside of Japan and China.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • 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.
  • Lecanemab, Aducanumab, and Gantenerumab - Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer's Disease.

Eisai to Present Latest Data on Lemborexant at the 37th Annual Sleep 2023 Meeting

Retrieved on: 
Friday, June 2, 2023
Associated, Eisai, Poster, Insomnia, Obstructive sleep apnea, Neurology, DSM-IV codes, Pharmaceutical industry

TOKYO, June 2, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO), will be given at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3 to 7, 2023 in Indianapolis, IN, the United States.

Key Points: 
  • TOKYO, June 2, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO), will be given at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3 to 7, 2023 in Indianapolis, IN, the United States.
  • Major poster presentations include new data about the effects of lemborexant on obstructive sleep apnea (poster numbers: #298, 299 and 300).
  • Eisai considers neurology, including insomnia, a therapeutic area of focus.
  • Eisai strives to create innovative products as soon as possible in therapeutic areas with high unmet medical needs, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with neurological diseases and their families.

LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, May 26, 2023
MSD, Senior, Hepatocellular carcinoma, Pharming, Sunitinib, Survival, Head, DO, Cancer, Patient, Stomatitis, Risk, Merck, Fatigue, Texas Oncology, Diarrhea, Pembrolizumab, FACP, Research, Lung cancer, Merck & Co., Hypertension, LEAP, HIV disease progression rates, Esophageal cancer, Abstract, Death, Apoptosis, Lenvatinib, Overalls, PFS, Eisai, CR, Stomach, ORR, Acral lentiginous melanoma, Arm, Progression-free survival, RCC, CI, OS, Drug, Trae tha Truth, Hypothyroidism, ASCO, Central Time Zone, American Society of Clinical Oncology, Cancer Treatment Centers of America, Physician, Annual general meeting, Nausea, Society, Pharmaceutical industry, EU

After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for LENVIMA plus KEYTRUDA versus 69.6% and 60.2% for sunitinib, respectively.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received LENVIMA plus KEYTRUDA versus 60.3% of patients who received sunitinib.
  • These findings reinforce the important role of LENVIMA plus KEYTRUDA as a first-line standard of care treatment option for patients with advanced renal cell carcinoma."

Eisai's Initiatives for Developing New Medicines for Neglected Tropical Diseases and Malaria and Commitment for Funding to the 3rd Phase of Global Health Innovative Technology Fund Activities

Retrieved on: 
Thursday, May 25, 2023
Vaccine, Infection, Partnership, Neglected tropical diseases, University, Anxiety, Research, Global Health Innovative Technology Fund, Drugs for Neglected Diseases Initiative, Filariasis, Organization, Mycetoma, Patient, Risk, Bill, Diagnosis, Health, Malaria, Pharmaceutical industry, Eisai

Eisai has provided a total of 1 billion yen to the first phase (FY2013 - FY2017) and the second phase (FY2018 - FY2022) of the GHIT Fund.

Key Points: 
  • Eisai has provided a total of 1 billion yen to the first phase (FY2013 - FY2017) and the second phase (FY2018 - FY2022) of the GHIT Fund.
  • In order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (NTDs) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome.
  • Eisai considers making efforts to resolve the global issue of access to medicines to be its duty.
  • Eisai is also conducting a Phase II clinical trial of antimalarial agent SJ733 in collaboration with the University of Kentucky.

Eisai Delivers New Data and Highlights Continued Progress of Oncology Portfolio and Pipeline at ASCO 2023

Retrieved on: 
Wednesday, May 24, 2023
MSD, CREB-binding protein, Apoptosis, Carcinoma, Abstract, Senior, CBP, FR, Pembrolizumab, Cancer, Fallopian tube cancer, Bristol Myers Squibb, Research, Lung cancer, Trial of the century, ASCO, LEAP, Endometrial cancer, American Society of Clinical Oncology, Patient, Physician, Sorafenib, Oncology nursing, Annual general meeting, ADC, Merck, Poster, Merck & Co., FDA, Survival analysis, Ovarian cancer, Society, HCC, Safety, Nivolumab, Pharmaceutical industry, Eisai

Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023.

Key Points: 
  • Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023.
  • A Phase 1/2 clinical study of BB-1701 in the U.S. and China for HER2-expressing solid tumors is currently underway.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • Eisai and Merck are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across more than multiple clinical trials.

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Great Britain

Retrieved on: 
Saturday, May 20, 2023
Health care, Lecanemab, Brain, Marketing, Clarity, Eisai, Co-promotion, MAA, Innovation, AD, Neurotoxicity, Alzheimer's disease, Disease, MHRA, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • As such, lecanemab may have the potential to have an effect on disease pathology and the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • 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.