BAN2401

BioArctic's partner Eisai publishes statement relating to article on lecanemab in Scienceinsider

Retrieved on: 
Friday, December 23, 2022
Nordic, Science, CET, Partnership, Commercialization, Safety, Clinical trial, Neurodegeneration, BAN2401, Eisai, Biogen, Parkinson's disease, ALS, Development, University, Pharmaceutical industry, Uppsala University, Alzheimer's disease

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease.

Key Points: 
  • Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease.
  • In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab.
  • Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease.
  • Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease.

BioArctic's partner Eisai initiates BLA submission of data for lecanemab in China

Retrieved on: 
Friday, December 23, 2022
Biologics license application, Trial of the century, Co-promotion, Clinical trial, National Medical Products Administration, Phase, Food, Prescription Drug User Fee Act, Brain, DIAD, CET, Disease, Partnership, National Institute on Aging, Washington University School of Medicine, Core, Commercialization, FDA, Safety, Priority review, Neurodegeneration, BLA, Clarity, AD, BAN2401, Eisai, PDUFA, MCI, The New England Journal of Medicine, NMPA, Parkinson's disease, Tau, Domination, ALS, Breakthrough therapy, Development, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ageing, University, Pharmaceutical industry, Medical device, Nordic, Alzheimer's disease, Uppsala University, Biogen

The registration category of lecanemab was designated as a Category 1 drug (innovative biologics not approved in China or any other countries).

Key Points: 
  • The registration category of lecanemab was designated as a Category 1 drug (innovative biologics not approved in China or any other countries).
  • Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA.
  • In July 2022, the FDA accepted Eisai's Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and granted it Priority Review.
  • 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's partner Eisai initiates BLA submission of data for lecanemab in China

Retrieved on: 
Friday, December 23, 2022
Biologics license application, Trial of the century, Co-promotion, Clinical trial, National Medical Products Administration, Phase, Food, Prescription Drug User Fee Act, Brain, DIAD, CET, Disease, Partnership, National Institute on Aging, Washington University School of Medicine, Core, Commercialization, FDA, Safety, Priority review, Neurodegeneration, BLA, Clarity, AD, BAN2401, Eisai, PDUFA, MCI, The New England Journal of Medicine, NMPA, Parkinson's disease, Tau, Domination, ALS, Breakthrough therapy, Development, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ageing, University, Pharmaceutical industry, Medical device, Nordic, Alzheimer's disease, Uppsala University, Biogen

The registration category of lecanemab was designated as a Category 1 drug (innovative biologics not approved in China or any other countries).

Key Points: 
  • The registration category of lecanemab was designated as a Category 1 drug (innovative biologics not approved in China or any other countries).
  • Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA.
  • In July 2022, the FDA accepted Eisai's Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and granted it Priority Review.
  • 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.

Frontage Partners with Eisai and Biogen to Complete the Clarity AD study for the Alzheimer's Drug, Lecanemab

Retrieved on: 
Monday, December 12, 2022
Biotechnology, Eisai, GFAP, Clinical trial, LC, Alzheimer's disease, AFL, EVP, PK, Drug discovery, Patient, Toxicology, BAN2401, Disease, Frontage, Contract research organization, News, Multimedia, Pharmacokinetics, Hope, PD, Pharmaceutical industry, NEJM

Recently Eisai/Biogen publicly shared the favorable results of the lecanemab (BAN2401) Clarity AD study which Eisai presented onNovember 29, 2022, at the Clinical Trials on Alzheimer's Disease Congress (CTAD), and published the findings in NEJM.

Key Points: 
  • Recently Eisai/Biogen publicly shared the favorable results of the lecanemab (BAN2401) Clarity AD study which Eisai presented onNovember 29, 2022, at the Clinical Trials on Alzheimer's Disease Congress (CTAD), and published the findings in NEJM.
  • The Frontage team developed and validated the LC-MS-based PK method back in 2010 and provided bioanalytical support to this program from clinical Phase 1 to the late phase trial.
  • Frontage's scientific team also provided biomarker analysis (p-Tau181, NfL, and GFAP) for this Phase 3 study and met the very aggressive timelines of data lock.
  • We are very proud to have worked closely with our Eisai partners to support the bioanalysis of lecanemab (BAN2401) in this large global phase 3 study.

AHEAD STUDY IS FIRST TO TEST LECANEMAB TO DELAY OR PREVENT ALZHEIMER'S DISEASE SYMPTOMS AT THE STAGE OF PRECLINICAL AD

Retrieved on: 
Wednesday, November 2, 2022
Amyloid, Plasma, Population, Headquarters, Clinical trial, Brain, Biomarker, Ageing, Research, PET, NIH, Harvard University, Risk, National Institute, Disease, Harvard Medical School, Safety, Neuroimaging, National, AD, Clarity, Biogen, BAN2401, Eisai, Dementia, NIA, Neurology, MCI, USC, ACTC, Multimedia, Clinical professor, SAN, Mayo Clinic, National Institute on Aging, Amnesia, Positron emission tomography, Medical imaging, Pharmaceutical industry, Online shopping, Alzheimer's disease

The AHEAD Study is the first ever clinical trial to test the effect of lecanemab (investigational antibody) in people who have no cognitive symptoms of Alzheimer's disease (AD), but in whom biomarker tests indicate amyloid is present in the brain, known as "preclinical" AD.

Key Points: 
  • The AHEAD Study is the first ever clinical trial to test the effect of lecanemab (investigational antibody) in people who have no cognitive symptoms of Alzheimer's disease (AD), but in whom biomarker tests indicate amyloid is present in the brain, known as "preclinical" AD.
  • The AHEAD Study is also the first AD trial to recruit people as young as 55 years old who are at risk of developing symptoms of AD as they get older.
  • The AHEAD Study will test whether the clinical effects reported in the Clarity AD clinically symptomatic population are similar in the AHEAD preclinical AD population.
  • "The AHEAD Study is testing lecanemab in a much earlier stage of AD than the Clarity AD trial," said Dr. Reisa Sperling, professor of neurology at Harvard Medical School, and co-principal investigator of the AHEAD Study.

Global Alzheimer's Therapeutics (Cholinesterase Inhibitors, Pipeline Drugs) Market Research Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 30, 2022
Pharmaceutical, Health, Neurology, Alzheimer's Association, National Institute, Hospital, Alzheimer's disease, Research, AIM, Therapy, Biogen, BAN2401, National Institute on Aging, USD, Incidence, High society, Risk, Rush Alzheimer's Disease Center, Alzheimer's Society, Neglected tropical disease research and development, Chapter Three, Eli Lilly, Medicare, Cholinesterase, FDA, Company, Dementia, United Kingdom, AD, Association, Eli Lilly and Company, Society, Patient, Pharmaceutical industry, Medical imaging, Fine chemical

The "Global Alzheimer's Therapeutics Market Size, Share & Trends Analysis Report by Product (Cholinesterase Inhibitors, Pipeline Drugs), by End Use, by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Alzheimer's Therapeutics Market Size, Share & Trends Analysis Report by Product (Cholinesterase Inhibitors, Pipeline Drugs), by End Use, by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.
  • Government organizations are engaged in providing funds for Alzheimer's support, care, and research activities, which is projected to fuel the market growth.
  • For instance, in March 2022, the Alzheimer's Society announced to spend around USD 3.5 billion in the coming years on dementia research to improve the care of patients.
  • According to Alzheimer's Association report 2022, approximately 32% of total Medicare beneficiaries with Alzheimer's have at least one hospital discharge annually
    Chapter 3 Alzheimer's Therapeutics Market Variables, Trends & Scope

Latest data on lecanemab presented at Alzheimer's Association International Conference (AAIC): BioArctic

Retrieved on: 
Friday, August 5, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Parkinson's disease, Commercialization, Biologics license application, PDUFA, BAN2401, Amyloid-related imaging abnormalities, Nasdaq Stockholm, AB, Clinical trial, Brain, National Institute, AAIC, Incidence, Biogen, National, Research, MCI, Eisai, Clarity, Patient, Review, Ageing, CET, Partnership, Safety, Prescription Drug User Fee Act, Neurodegeneration, Genotype, AD, University, BLA, Nasdaq, National Institute on Aging, Conference, Development, ALS, Food, Disease, Person, Pharmaceutical industry, Apolipoprotein E, Alzheimer's disease, Uppsala University

Eisai presented lecanemab data and research in one oral and eight poster presentations at the meeting.

Key Points: 
  • Eisai presented lecanemab data and research in one oral and eight poster presentations at the meeting.
  • "Eisai's broad clinical program for lecanemab continues to deliver data regarding how lecanemab could be used as a potential disease-modifying treatment for patients with Alzheimer's disease.
  • Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between BioArctic and Eisai.
  • In June 2021, FDA granted lecanemab Breakthrough Therapy designation and in December 2021, FDA granted lecanemab Fast track designation.

Latest data on lecanemab presented at Alzheimer's Association International Conference (AAIC): BioArctic

Retrieved on: 
Friday, August 5, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Parkinson's disease, Commercialization, Biologics license application, PDUFA, BAN2401, Amyloid-related imaging abnormalities, Nasdaq Stockholm, AB, Clinical trial, Brain, National Institute, AAIC, Incidence, Biogen, National, Research, MCI, Eisai, Clarity, Patient, Review, Ageing, CET, Partnership, Safety, Prescription Drug User Fee Act, Neurodegeneration, Genotype, AD, University, BLA, Nasdaq, National Institute on Aging, Conference, Development, ALS, Food, Disease, Person, Pharmaceutical industry, Apolipoprotein E, Alzheimer's disease, Uppsala University

Eisai presented lecanemab data and research in one oral and eight poster presentations at the meeting.

Key Points: 
  • Eisai presented lecanemab data and research in one oral and eight poster presentations at the meeting.
  • "Eisai's broad clinical program for lecanemab continues to deliver data regarding how lecanemab could be used as a potential disease-modifying treatment for patients with Alzheimer's disease.
  • Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between BioArctic and Eisai.
  • In June 2021, FDA granted lecanemab Breakthrough Therapy designation and in December 2021, FDA granted lecanemab Fast track designation.

Eisai Presents New Findings on Lecanemab's Investigational Subcutaneous Formulation and Modeling Simulation of ApoE4 Genotype on Aria-E Incidence at AAIC 2022

Retrieved on: 
Thursday, August 4, 2022
BAN2401, Alzheimer's disease, Senior, PHASE 2, Brain, Disease, BLA, ARIA, Food, Review, PET, Biologics license application, Safety, FDA, AAIC, Genotype, Biogen, AD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Clarity, Prescription Drug User Fee Act, OLE, CA, IV, Neutralizing antibody, AUC, Incidence, Cmax, Conference, PDUFA, MCI, Caregiver, Pharmaceutical industry, Patient, Single, Apolipoprotein E, Eisai

Lecanemab PK for the 5 Japanese subjects was similar to that of the non-Japanese subjects following a single subcutaneous dose administration.

Key Points: 
  • Lecanemab PK for the 5 Japanese subjects was similar to that of the non-Japanese subjects following a single subcutaneous dose administration.
  • The modeling will be updated with data from Eisai's Phase 3 Clarity AD confirmatory study reading out in fall 2022."
  • This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety.
  • There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

Eisai to Present at The Alzheimer's Association International Conference (AAIC) 2022

Retrieved on: 
Tuesday, July 26, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CA, Pathology, Biologics license application, Amyloid beta, AAIC, Core, Brain, Knowledge, Diagnosis, BLA, University School, BAN2401, Alzheimer's Disease Neuroimaging Initiative, Research, Food, Incidence, Clarity, Categorization, Biomarker, Disease, Domination, PET, Comprehensive, APOE4, George Washington University School of Medicine & Health Sciences, Safety, Autumn, Conference, Prescription Drug User Fee Act, CSF, Review, AD, FDA, Senior, 2009 Davis Cup, Patient, Pharmacokinetics, Poster, Oral, MCI, Plasma, PDUFA, Medical imaging, Eisai, Genotype, Alzheimer's disease

Eisai will present data and research in three oral and 18 poster presentations at the meeting.

Key Points: 
  • Eisai will present data and research in three oral and 18 poster presentations at the meeting.
  • The readout of the primary endpoint data of Clarity AD will occur in the Fall of 2022.
  • The FDA has agreed that the results of Clarity AD when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.
  • (Poster/Abstract #69438)
    Modeling and simulation analysis aimed at showing the equivalence of fixed weekly subcutaneous dose of lecanemab to body weight-based 10mg/kg biweekly intravenous dose.