Co-promotion

"LEQEMBI Intravenous Infusion" (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Japan

Retrieved on: 
Monday, September 25, 2023
Amyloid-related imaging abnormalities, PMID, Outline, Clinical trial, Marketing, The New England Journal of Medicine, Deficit spending, Pathology, Ministry of Health, Labour and Welfare, Research, Brain, Siderosis, History, MCI, The Different Forms of Flowers on Plants of the Same Species, Clarity, Ministry, ARIA, Dementia, HIV disease progression rates, Patient, Immunoglobulin G, Superficial siderosis, PLOS One, Co-promotion, Ministry of Health (Kuwait), Therapy, Headache, Neurotoxicity, Disease, ADCS, Pharmaceutical industry, Alzheimer's disease, Biogen, Amyloid beta, Health, Eisai

Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.

Key Points: 
  • Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.
  • In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.
  • "Today LEQEMBI received approval, making it the first 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 in Japan.
  • In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.

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.

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 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.

Scribe Therapeutics Expands Collaboration with Sanofi to Advance In Vivo Genetic Medicines for Sickle Cell and Other Genomic Diseases

Retrieved on: 
Monday, July 17, 2023
Biotechnology, Pharmaceutical, Genetics, Health, XE, CRISPR, Drug development, Therapy, Collaboration, Cancer, Co-promotion, NK, Research, Patient, Sickle cell disease, Toxic epidermal necrolysis, LNP, Gene, Disease, Genome, Pharmaceutical industry, Sanofi, Scribe

Scribe Therapeutics Inc., a genetic medicines company unlocking the potential of CRISPR to transform human health, today announced an expanded collaboration with Sanofi (NASDAQ: SNY).

Key Points: 
  • Scribe Therapeutics Inc., a genetic medicines company unlocking the potential of CRISPR to transform human health, today announced an expanded collaboration with Sanofi (NASDAQ: SNY).
  • Under the agreement, Sanofi receives an exclusive license to use Scribe’s CRISPR X-Editing (XE) genome editing technologies for the development of in vivo therapies, including sickle cell disease.
  • The agreement follows the launch of the companies’ existing collaboration focused on ex vivo editing of natural killer (NK) cell therapies for the treatment of cancer.
  • The in vivo collaboration will leverage Scribe’s precisely engineered CRISPR XE technologies and Sanofi’s capabilities in non-viral delivery to address an initial target for sickle cell disease.

EISAI TO PRESENT THE LATEST ALZHEIMER'S DISEASE PIPELINE AND RESEARCH, INCLUDING LECANEMAB AND ANTI-MTBR TAU ANTIBODY E2814, AT THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2023

Retrieved on: 
Wednesday, July 12, 2023
PMID, Huber loss, Onset, Brain, Comorbidity, The Different Forms of Flowers on Plants of the Same Species, Eisai, MRI, Pharmacokinetics, PLOS One, Co-promotion, Immunogenicity, Medical imaging, Pharmaceutical industry, Alzheimer's disease, Safety

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety.

Key Points: 
  • This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety.
  • There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
  • Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE.
  • 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.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, 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).
  • 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.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, 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).
  • 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.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Societal value of lecanemab in Japan published in Neurology and Therapy

Retrieved on: 
Wednesday, May 17, 2023
Neurology, Eisai, Quality of life, Health, AD, CET, Caregiver, Co-promotion, Pharmaceutical industry, Biogen

The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce medical costs, public care costs and caregiver burden for individuals with early AD and their caregivers in Japan.

Key Points: 
  • The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce medical costs, public care costs and caregiver burden for individuals with early AD and their caregivers in Japan.
  • 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.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • The information was released for public disclosure, through the agency of the contact person below, on May 17, 2023, at 01.30 a.m. CET.