Lecanemab

ALZHEIMER'S ASSOCIATION WELCOMES U.S. FDA TRADITIONAL APPROVAL OF LEQEMBI: FULL DETAILS

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torsdag, juli 6, 2023
Well, Amyloid-related imaging abnormalities, Doctor of Public Health, Network, Bleeding, Alzheimer's Association, Food and Drug Administration, Brain, Multimedia, Dementia, Medicare, AAIC, ARIA, Amyloid, Patient, Risk, Love, Hearing, Genetic testing, Diagnosis, Helpline, FDA, Conference, Treatment, Food, Disease, Pharmaceutical industry, Medical imaging, Residential care, Alzheimer's disease, Lecanemab

This is the first traditional approval of an Alzheimer's treatment that changes the underlying course of the disease.

Key Points: 
  • This is the first traditional approval of an Alzheimer's treatment that changes the underlying course of the disease.
  • Well-conducted clinical trials clearly demonstrate that removing amyloid from the brain provides measurable, meaningful benefit in people with early Alzheimer's.
  • Leqembi has been on the market since January 2023, when it received accelerated approval from the FDA.
  • "I was in the Leqembi clinical trial, so I am really excited about today's FDA approval.

ADDF Statement On FDA's Traditional Approval of Lecanemab (Leqembi)

Retrieved on: 
torsdag, juli 6, 2023
Fillit, Drug development, Therapy, Ageing, Brain, Research, Biomarker, Inflammation, Pathology, Dementia, MD, Patient, Alzheimer's Drug Discovery Foundation, Investment, Medicine, Biology, Diagnosis, Entrepreneurship, FDA, News, Disease, Medical device, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Lecanemab

NEW YORK, July 6, 2023 /PRNewswire/ -- Today's FDA approval of the monoclonal antibody lecanemab (Leqembi) for the treatment of patients with mild cognitive impairment or early stage Alzheimer's disease and confirmed amyloid plaques in the brain is a significant milestone. This marks the first time a disease-modifying treatment for Alzheimer's has received traditional approval, and the first time that any Alzheimer's treatment has been converted from accelerated to full traditional approval by the FDA. 

Key Points: 
  • This marks the first time a disease-modifying treatment for Alzheimer's has received traditional approval, and the first time that any Alzheimer's treatment has been converted from accelerated to full traditional approval by the FDA.
  • "This is encouraging news, and more importantly, the approval of Leqembi will serve as a catalyst for driving further developments and investments in the Alzheimer's pipeline," says Howard Fillit, MD, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF).
  • Anti-amyloid drugs are an important starting point, but they only address one of several pathways associated with the disease.
  • "While we celebrate the FDA approval of Leqembi, we acknowledge that the journey towards effective treatments for Alzheimer's is still in its early days," adds Dr. Fillit.

UsAgainstAlzheimer’s Applauds FDA Approval of Leqembi for Treatment of Early-Stage Alzheimer’s

Retrieved on: 
torsdag, juli 6, 2023
CMS, Centers for Medicare & Medicaid Services, Registry, Senior advisor, Clinical trial, Health equity, Hope, Woman, Attention, Medicare, Criticism of the Food and Drug Administration, Patient, Risk, Physician, FDA, News, Food, Disease, Pharmaceutical industry, Lecanemab

Washington, DC, July 06, 2023 (GLOBE NEWSWIRE) -- Patient advocacy organization UsAgainstAlzheimer’s today hailed the first-of-its-kind traditional approval by the Food and Drug Administration (FDA) of lecanemab (marketed as Leqembi), a treatment for early-stage Alzheimer’s.

Key Points: 
  • Washington, DC, July 06, 2023 (GLOBE NEWSWIRE) -- Patient advocacy organization UsAgainstAlzheimer’s today hailed the first-of-its-kind traditional approval by the Food and Drug Administration (FDA) of lecanemab (marketed as Leqembi), a treatment for early-stage Alzheimer’s.
  • UsAgainstAlzheimer’s celebrated the news and reiterated its call for immediate access to the treatment.
  • Finally, we have a drug that can slow the encroachment of Alzheimer’s into our families’ lives and livelihoods.
  • “The scientists at FDA are in the best position to determine whether a drug is safe and effective.

Quanterix Launches LucentAD Biomarker Blood Test to Aid Physician Diagnosis of Alzheimer’s Disease in Patients

Retrieved on: 
torsdag, juli 6, 2023
Mental Health, Research, Neurology, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, Science, University, Lucent, Anxiety, Pathology, DSM-IV codes, Deficit spending, Brain, Biomarker, Cerebrospinal fluid, Associate, Plasma, Alzheimer's disease, Dementia, TEM Toloue-4, CLIA, Corporation, Amyloid, MD, Patient, Blood, Psychiatry, Diagnosis, AD, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Medical imaging, Pharmaceutical industry, Medical device, Lecanemab

The LucentAD test is run by Quanterix’s CLIA laboratory , which powers many of the clinical trials associated with AD.

Key Points: 
  • The LucentAD test is run by Quanterix’s CLIA laboratory , which powers many of the clinical trials associated with AD.
  • Lucent Diagnostics is Quanterix’s new healthcare provider-facing portal, launched to meet the needs of patients at the same time a therapy for the disease has become more widely available.
  • “A year ago, Quanterix announced the validation of our laboratory developed test to quantitatively measure p-Tau 181 in plasma as an aid in diagnostic evaluation of Alzheimer’s disease,” said Masoud Toloue, CEO at Quanterix.
  • The LucentAD test was developed and validated by Quanterix Corporation (CLIA# 22D1053083) in a manner consistent with CLIA requirements.

Soleo Health Prepared to Meet Increased Demand of FDA-Approved LEQEMBI™ (lecanemab-irmb) to Treat Alzheimer’s Disease

Retrieved on: 
torsdag, juli 6, 2023
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In January 2023, Soleo Health was selected by Eisai Inc., a developer of pharmaceuticals, as the specialty pharmacy distribution partner for LEQEMBI to treat Alzheimer’s Disease. At that time, the highly anticipated treatment -- an anti-amyloid monoclonal antibody used to treat mild cognitive impairment (MCI) due to Alzheimer’s Disease and mild Alzheimer’s Disease (collectively known as early Alzheimer’s Disease) -- had received fast-track FDA approval initially. Today, LEQEMBI received full FDA approval.

Key Points: 
  • In January 2023, Soleo Health was selected by Eisai Inc., a developer of pharmaceuticals, as the specialty pharmacy distribution partner for LEQEMBI to treat Alzheimer’s Disease.
  • At that time, the highly anticipated treatment -- an anti-amyloid monoclonal antibody used to treat mild cognitive impairment (MCI) due to Alzheimer’s Disease and mild Alzheimer’s Disease (collectively known as early Alzheimer’s Disease) -- had received fast-track FDA approval initially.
  • Soleo Health’s distinctive Alzheimer’s Disease TCMC is supported through the Company’s specialty pharmacy locations nationwide with pharmacy licensure in all 50 states.
  • For more information about LEQEMBI therapy and services through Soleo Health, contact the Company’s Alzheimer’s Disease TCMC at 844.960.9090 or email [email protected] .

FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval

Retrieved on: 
torsdag, juli 6, 2023
Amyloid-related imaging abnormalities, Myenteric plexus, Hypersensitivity, Seizure, Neuron, Intracerebral hemorrhage, Bleeding, Clinical Dementia Rating, Center for Drug Evaluation and Research, Trial of the century, Disease, Clinical trial, Brain, Risk, Angioedema, Antibody, DSM-IV codes, Accelerated approval (FDA), Incidence, Anticoagulant, ARIA, Dizziness, Amyloid, Allergy, Patient, Swelling, Anaphylaxis, CLARITY, Peripheral, Nausea, Confusion, Research, FDA, Headache, Caregiver, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Medical imaging, Pharmaceutical industry, Alzheimer's disease, Lecanemab

SILVER SPRING, Md., July 6, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer's Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer's disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease. 

Key Points: 
  • Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer's disease.
  • "This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease."
  • Treatment was initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology.
  • The labeling states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

ADDF STATEMENT ON FDA ADVISORY COMMITTEE'S ENDORSEMENT OF LECANEMAB (LEQEMBI)

Retrieved on: 
fredag, juni 9, 2023
Fillit, Alzheimer's disease, Ageing, Biomarker, Patient, Alzheimer's Drug Discovery Foundation, Drug combination, PDUFA, Biology, Diagnosis, Entrepreneurship, Pharmaceutical industry, Medical imaging, Lecanemab

NEW YORK, June 9, 2023 /PRNewswire/ -- Today, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that lecanemab (leqembi) showed clinical benefit in early Alzheimer's disease, paving the way for a traditional approval of the drug. This milestone comes just ahead of its July 6th PDUFA date and if approved, Leqembi will be the first-ever disease-modifying treatment for Alzheimer's to receive full approval.

Key Points: 
  • This milestone comes just ahead of its July 6th PDUFA date and if approved, Leqembi will be the first-ever disease-modifying treatment for Alzheimer's to receive full approval.
  • "We are encouraged by the FDA Advisory Committee's decision to endorse Leqembi, but we recognize that the mission to develop effective treatments for all patients with Alzheimer's disease is far from over," says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF).
  • As more new therapies move from discovery to development, there is an increased need to develop and utilize complimentary biomarkers and diagnostic tools that can identify the populations that will most benefit from various treatments.
  • "Biomarkers offer the ability to match the right drugs to the right patients at the right time," says Dr. Fillit.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
måndag, maj 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: 
måndag, maj 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.

Alzheimer Society of Ontario Applauds First Step Towards Approved Treatment for Alzheimer’s Disease in Canada

Retrieved on: 
onsdag, maj 17, 2023
University, Alzheimer Society of Ontario, Agility, Alzheimer Society of Canada, Dementia, HIV disease progression rates, Risk, Diagnosis, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Food, Pharmaceutical industry, Medical imaging, Lecanemab

If approved, Leqembi would be Canada’s first treatment for Alzheimer’s disease—not just its symptoms.

Key Points: 
  • If approved, Leqembi would be Canada’s first treatment for Alzheimer’s disease—not just its symptoms.
  • “Two years ago the world had no approved treatments for Alzheimer’s disease.
  • It is vital that we get the introduction of this first treatment right.”
    Research out of the University of Southern California released last year, sponsored by the Alzheimer Society of Ontario, found that Ontario is not ready for the now-foreseeable arrival of an approved treatment for Alzheimer’s disease.
  • To be most effective Leqembi, along with two other promising treatments for Alzheimer’s disease, must be administered early in disease progression.