Lecanemab

Eisai Presents Latest Analysis of Lecanemab's Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer's Association International Conference (AAIC) 2023

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torsdag, juli 20, 2023
PK, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GFAP, Glial fibrillary acidic protein, Clinical trial, SC, The New England Journal of Medicine, Pathology, PET, Brain, Biomarker, Clarity, Plasma, AAIC, Fluid mechanics, Amyloid, Astrocyte, Neurogranin, Lecanemab, AD, FDA, Conference, Food, Safety, Biogen, Medical imaging, Pharmaceutical industry, Alzheimer's disease, CSF

This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.

Key Points: 
  • This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.
  • The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease (AD) on July 6, 2023.
  • In an exposure/bioavailability and modeling study comparing intravenous (IV) and subcutaneous (SC) dosing of lecanemab, the bioavailability of SC dosing of lecanemab was shown to be approximately 50% of that of IV dosing.
  • 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.

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

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onsdag, juli 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: 
fredag, juli 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 Files Marketing Authorization Application for Lecanemab as Treatment For Early Alzheimer's Disease in South Korea

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torsdag, juni 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: 
lördag, maj 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.

Eisai Presents Latest Analysis of Lecanemab's Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer's Association International Conference (AAIC) 2023

Retrieved on: 
torsdag, juli 20, 2023
PK, GFAP, Glial fibrillary acidic protein, Clinical trial, SC, Biogen, The New England Journal of Medicine, BIIB, Pathology, PET, Brain, Biomarker, Clarity, Plasma, Eisai, AAIC, Fluid mechanics, Amyloid, Headquarters, Corporation, Astrocyte, Neurogranin, Lecanemab, AD, FDA, Conference, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Medical imaging, Pharmaceutical industry, Alzheimer's disease, CSF

TOKYO and CAMBRIDGE, Mass., July 19, 2023 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the results of a detailed analysis of the Phase 3 Clarity AD study demonstrated that lecanemab-irmb (generic name, U.S. brand name: LEQEMBI®) treatment showed reductions in amyloid-beta (Aβ) pathology and downstream biomarker changes. This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023. The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease (AD) on July 6, 2023.

Key Points: 
  • This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.
  • These outcomes suggested lecanemab impacts A/T/N+ biomarkers involved in the AD pathophysiology and exerts biological effects that demonstrate slowing of disease progression.
  • In an exposure/bioavailability and modeling study comparing intravenous (IV) and subcutaneous (SC) dosing of lecanemab, the bioavailability of SC dosing of lecanemab was shown to be approximately 50% of that of IV dosing.
  • 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.

BrainCheck Celebrates U.S. FDA Approval of Leqembi® and Empowers Customers to Lead the Way in Early Detection of Cognitive Impairment

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måndag, juli 17, 2023
Disease, Education, Alzheimer's disease, Montreal Cognitive Assessment, Stanford University, Anxiety, Lecanemab, Deficit spending, Dignity, MBA, Research, Doctor of Philosophy, Science, Dementia, AAIC, Patient, Physician, Neurology, Baylor College of Medicine, Diagnosis, Knowledge, FDA, Health, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Neuroscientist, Food, Pharmaceutical industry, Nursing, Medical imaging, Hospital

AUSTIN, Texas, July 17, 2023 /PRNewswire/ -- BrainCheck, Inc. celebrates the U.S. Food and Drug Administration (FDA)'s recent decision to approve Leqembi® (lecanemab, Eisai/Biogen), for the treatment of early Alzheimer's disease. BrainCheck's comprehensive cognitive assessment and care management platform is empowering customers to lead the way in the early detection of cognitive impairment. Kim Rodriguez, CEO, and Matt Cerullo, Chief Revenue Officer, will attend the Alzheimer's Association International Conference (AAIC) in Amsterdam, Netherlands from July 16-20 to share BrainCheck's technology with the global dementia research community.

Key Points: 
  • BrainCheck's comprehensive cognitive assessment and care management platform is empowering customers to lead the way in the early detection of cognitive impairment.
  • "The U.S. FDA's approval of Leqembi® marks a major milestone in the fight against Alzheimer's disease.
  • With the approval specifically focused on the treatment of patients with early forms of disease, such as mild cognitive impairment or mild dementia, early detection has never been more important," said Kim Rodriguez, CEO of BrainCheck.
  • "We developed the BrainCheck platform because we believe that in the battle against Alzheimer's disease and dementia, early detection is the best defense.

SYNAPS Dx DISCERN™ Test Provides Accurate Diagnosis of Alzheimer’s Disease, Optimizes Prescribing, Minimizes Patient Risks and Informs Coverage Decisions for Leqembi™

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tisdag, juli 11, 2023
Health, FDA, Neurology, Research, Science, Pharmaceutical, Biotechnology, Amyloid-related imaging abnormalities, DISCERN, Synaptic, Software-defined, Physician, Food, Food and Drug Administration, Brain, Risk, ARIA, Dementia, Patient, Diagnosis, AD, Autopsy, Skin, Safety, Disease, Pharmaceutical industry, Medical imaging, Lecanemab

Pursuant to the Leqembi label , once AD is identified, then an assessment of amyloid positivity can be performed in determining if the drug is appropriate.

Key Points: 
  • Pursuant to the Leqembi label , once AD is identified, then an assessment of amyloid positivity can be performed in determining if the drug is appropriate.
  • In clinical utility studies, clinicians were four times more likely to prescribe drugs like Leqembi with a positive DISCERN test than if the test was negative.
  • The established relationship between AD and the skin provides unique positioning for DISCERN which requires a minimally invasive, 3mm skin punch biopsy .
  • “AD is complex but DISCERN resolves the diagnostic dilemma , enabling physicians to make a more definitive diagnosis,” continues Amato.

Alzheimer's Association Welcomes Announcement of CMS Coverage for FDA-approved Treatments

Retrieved on: 
fredag, juli 7, 2023
White House, Doctor of Public Health, CMS, Network, Centers for Medicare & Medicaid Services, Alzheimer's Association, Policy, Food and Drug Administration, Public policy, National coverage determination, Multimedia, Lecanemab, White, Congress, Registry, Dementia, Patient, Physician, Diagnosis, Helpline, Health, FDA, Information services, Treatment, Health care, Pharmaceutical industry, Residential care, Alzheimer's disease, Medicare, Food

It is clear that CMS leaders have listened to experts, advocates, people living with Alzheimer's and families.

Key Points: 
  • It is clear that CMS leaders have listened to experts, advocates, people living with Alzheimer's and families.
  • It is reflected in their plan for delivering coverage of traditionally approved treatments proven to deliver meaningful benefit," said Joanne Pike, DrPH, Alzheimer's Association president and CEO.
  • Today's announcement by CMS to open up Medicare coverage comes following extensive efforts by the Alzheimer's Association, bipartisan members of Congress , state attorneys general , clinicians, and, most importantly, advocates from communities all across the country.
  • "We were disappointed, however, that CMS did not take this opportunity to initiate the formal process to reconsider their National Coverage Determination policy .

Breakthrough in Alzheimer’s Disease Treatment: Alzheimer Society of Ontario Applauds US Approval of Game-Changing Disease-Modifying Therapy

Retrieved on: 
torsdag, juli 6, 2023
University, Hope, Alzheimer Society of Ontario, Research, Government, Dementia, Risk, Diagnosis, Health Canada, US FDA, Disease, Pharmaceutical industry, Lecanemab

TORONTO, July 06, 2023 (GLOBE NEWSWIRE) -- The Alzheimer Society of Ontario welcomes today’s US FDA decision to grant full approval to lecanemab (brand name: Leqembi), a disease-modifying therapy for Alzheimer’s disease.

Key Points: 
  • TORONTO, July 06, 2023 (GLOBE NEWSWIRE) -- The Alzheimer Society of Ontario welcomes today’s US FDA decision to grant full approval to lecanemab (brand name: Leqembi), a disease-modifying therapy for Alzheimer’s disease.
  • This marks the first full approval of any treatment for Alzheimer’s disease globally, and marks the latest positive step forward for research into therapeutic and diagnosis options.
  • “Helplessness is steadily giving way to hope,” said Cathy Barrick, CEO of the Alzheimer Society of Ontario.
  • “We have had years of advance notice that treatment options for Alzheimer’s disease are coming to Ontario,” continued Ms. Barrick.