Lecanemab

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Neurophet to unveil new technology for analyzing ARIA side effect at ECR 2023

Retrieved on: 
Thursday, March 2, 2023
European, Prognosis, Multimedia, Congress, MRI, FDA, AI, Myenteric plexus, Dementia, Edema, Observation, PET, Radiology, WMH, ECR, Patient, European Congress of Radiology, AQUA, Health, SWI, ARIA, LAB, Atrophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Multiple sclerosis, Diagnosis, Vascular dementia, Biomarker, Food, Bleeding, GRE, Artificial intelligence, Brain, Medical device, Medical imaging, Pharmaceutical industry, Lecanemab, Alzheimer's disease

Neurophet SCALE PET is an AI-based PET image analysis software that quantifies PET tracer bindings automatically.

Key Points: 
  • Neurophet SCALE PET is an AI-based PET image analysis software that quantifies PET tracer bindings automatically.
  • Neurophet is carrying out the ATNV Project, a national research project using the flagship products Neurophet AQUA and Neurophet SCALE PET funded by Korea dementia research center.
  • Monitoring and management of ARIA are essential for prescribing anti-amyloid antibody drugs, and it seems to be possible to analyze ARIA through Neurophet's ATNV project technology.
  • He added, "The vascular neuropathology quantification technology for analyzing WMH and ARIA-H could also be used to diagnose multiple sclerosis, and the technology is being advanced."

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Tuesday, February 28, 2023
Amyloid beta, Ministry of Health, Labour and Welfare, Lecanemab, Alzheimer's disease, Ministry, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, Brain, Research, The New England Journal of Medicine, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Key Points: 
  • TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • In the U.S., lecanemab was granted accelerated approval 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.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Monday, February 27, 2023
Ministry of Health, Labour and Welfare, Lecanemab, Ministry, BIIB, Corporation, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, The New England Journal of Medicine, Brain, Research, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Headquarters, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.

Key Points: 
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • In the U.S., lecanemab was granted accelerated approval 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.

Global Alzheimer’s Platform Foundation (GAP) President Blasts CMS’ “Unprecedented and Pernicious” Discrimination Against People with Alzheimer’s Disease

Retrieved on: 
Thursday, February 23, 2023
Congress, Quality of life, Lecanemab, CED, Disease, Life, Insurance, FDA, Patient, CMS, Hope, Pernicious, Medicare, Centers for Medicare & Medicaid Services, Caregiver, Memory, Physician, Pharmaceutical industry

CMS’s latest decision on disease-modifying therapies for Alzheimer’s patients is effectively a coverage denial for this entire class of drugs, and patients will needlessly die as a result of it.

Key Points: 
  • CMS’s latest decision on disease-modifying therapies for Alzheimer’s patients is effectively a coverage denial for this entire class of drugs, and patients will needlessly die as a result of it.
  • This decision continues the agency’s unprecedented and pernicious actions against the Alzheimer’s community, which take treatment options — and hope — away from people with this heinous disease.
  • In its latest decision, CMS continues to erect additional barriers to access in the form of a ‘coverage with evidence’ (CED) requirement on an already FDA-approved drug.
  • This denies access to poor, rural and medically underserved communities — and CMS’s past CED initiatives demonstrate this.

Bellevue Asset Management AG: Emerging Markets Healthcare sector comeback

Retrieved on: 
Wednesday, February 22, 2023
Pharmacy, Government, Lecanemab, Private Asset Management, Graubündner Kantonalbank, Daiichi Sankyo, Investment, Zanubrutinib, Breast cancer, WuXi Biologics, Patient, Cardiology, Business administration, Hip, Biogen, Zurich University of Applied Sciences/ZHAW, Policy, Health care, BeiGene, Growth, Health, Applied science, COVID, Multiple myeloma, BTK, Apollo Hospitals, AstraZeneca, Elective surgery, Cancer, Zurich University, Sun Pharma, Pharmaceutical industry

After a string of difficult years, a trend reversal is under way in emerging market healthcare stocks.

Key Points: 
  • After a string of difficult years, a trend reversal is under way in emerging market healthcare stocks.
  • In the Bellevue Emerging Markets Healthcare Fund, the China allocation is more than 60% and in the Bellevue Asia Pacific Healthcare Fund it is about 40%.
  • Remo Krauer has been a Senior Portfolio Manager Healthcare Funds & Mandates at Bellevue Asset Management since 2018.
  • Previously, he worked at Zürcher Kantonalbank, first as Senior Portfolio Manager, then as Head Portfolio Construction for Private Asset Management.

Emory Healthcare Engages Linus Health on Initiative to Expand Early Detection of Alzheimer’s Disease and Other Dementias

Retrieved on: 
Thursday, February 16, 2023
Health Technology, Health, Neurology, Brain, Dementia, IPad, Lecanemab, Myenteric plexus, Patient, Digital technology, Internal medicine, Research, Emory Healthcare, Goizueta, Health care, Disease, Deficit spending, FDA, PCP, Cognition, Doctor of Philosophy, MD, Medical imaging

Linus Health , a digital health company focused on transforming brain health, today announced that the Goizueta Institute @Emory Brain Health and The Seavey Clinic at Emory Healthcare are working with the company to implement innovative digital cognitive assessments in primary care.

Key Points: 
  • Linus Health , a digital health company focused on transforming brain health, today announced that the Goizueta Institute @Emory Brain Health and The Seavey Clinic at Emory Healthcare are working with the company to implement innovative digital cognitive assessments in primary care.
  • The collaboration is designed to evaluate and operationalize the use of digital technology to help primary care providers (PCPs) spot Alzheimer’s disease and other dementias at their earliest stages and intervene as early as possible.
  • An estimated 50 million people around the world currently have Alzheimer’s disease and other dementias and that number is growing by almost 10 million people every year.
  • “Emory Healthcare is a brain health pioneer and we’re honored that they’ve chosen us to support their efforts to improve patients’ lives through earlier detection and intervention.

Linus Health Earns Numerous Awards as Digital Health Pioneer in Alzheimer’s and Other Dementia

Retrieved on: 
Tuesday, January 24, 2023
Health, Technology, Neurology, Health Technology, Software, General Health, Artificial Intelligence, Biomarker, IPad, Linus, Acquisition, Built-in, Davos, Tech, Ecosystem, Deficit spending, Invention, Dementia, Mass, Doctor of Philosophy, Nursing, Pharmaceutical industry, Lecanemab, Association of British HealthTech Industries, Medtech

Linus Health , a digital health company focused on transforming brain health, today announced that it recently won awards in several prominent recognition programs, including Mass Technology Leadership Council’s (Mass TLC) Tech Top 50 Awards, BostInno’s Fire Awards , and Built In Boston’s 2023 Best Places to Work Awards .

Key Points: 
  • Linus Health , a digital health company focused on transforming brain health, today announced that it recently won awards in several prominent recognition programs, including Mass Technology Leadership Council’s (Mass TLC) Tech Top 50 Awards, BostInno’s Fire Awards , and Built In Boston’s 2023 Best Places to Work Awards .
  • In October, Linus Health received top honors as “Technology of the Year” in the Healthcare Tech category of Mass TLC's Tech Top 50 award program.
  • Linus Health also earned recognition in the 2022 BostInno Fire Awards program as one of the stand-outs in Medtech and Healthtech.
  • Most recently, Built In featured Linus Health on its 2023 Best Places to Work in Boston list.

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Retrieved on: 
Friday, July 30, 2021
Branches of biology, Amyloidosis, Monoclonal antibodies, Biology, Health sciences, Alzheimer's disease, Lecanemab, Clinical trial, Amyloid beta, Amyloid, Crenezumab, Gantenerumab

The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.

Key Points: 
  • The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
  • In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer's disease, were presented.
  • For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented.
  • "It's very encouraging to see that Eisai's broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes.