Lecanemab

Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA

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星期一, 四月 1, 2024
Biogen, FDA, Brain, Administration, MCI, State, Fast Track, Dementia, Cell, Clarity, Eisai, Biologics license application, European, Alzheimer's disease, OLE, Patient, BLA, Neuron, Plaque, Lecanemab

LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

Key Points: 
  • LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
  • Eisai had aimed to submit a Biologics License Application (BLA) for weekly maintenance therapy using subcutaneous (SC) administration in March 2024.
  • However, Eisai was recently informed by the FDA that a Fast Track designation specific for the SC formulation is needed to receive rolling review.
  • Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

EISAI TO PRESENT DATA ON ROBUST NEUROLOGY PORTFOLIO AT THE 76th AMERICAN ACADEMY OF NEUROLOGY® (AAN) ANNUAL MEETING

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星期五, 四月 12, 2024
Amyloid, Angioedema, Brain, Anticoagulant, Neuroimaging, Patient, Vascular malformation, Lecanemab, Siderosis, Dementia, Cell, Seizure, ARIA, Risk, Aspirin, Focal neurologic signs, Nausea, Cerebral edema, Dizziness, Paracetamol, Arthralgia, Cerebral amyloid angiopathy, Effectiveness, Genetic testing, Intraparenchymal hemorrhage, Observation, Confusion, Alzheimer's disease, Intracerebral hemorrhage, Status epilepticus, Vomiting, Incidence, Aneurysm, Anaphylaxis, Headache, Hypersensitivity, Hypertension, MRI, Magnetic resonance imaging, Chills, Neuron, Bronchospasm, Fatal, Hypotension, Tissue plasminogen activator, Edema, Fever, Excipient, Pharmaceutical industry

Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Key Points: 
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E.
  • There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.

How Do Companies Avert Further Frustration among Neurologists Due to Relyvrio’s (Amylyx) Phase 3 Failure and Donanemab’s (Lilly) FDA delay?

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星期二, 三月 12, 2024
Diagnosis, Lecanemab, Alzheimer's disease, ALS, Sodium phenylbutyrate/ursodoxicoltaurine, Caregiver, Patient, Amyotrophy, News, Hope, Life, Life expectancy, Lilly, FDA, Donanemab, Pharmaceutical industry

ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.

Key Points: 
  • ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.
  • ALS patients maintain their cognitive functions while their muscle function deteriorates and eventually renders them bed-ridden, unable to swallow, and unable to breathe.
  • In an unusual decision the FDA conditionally approved Relyvrio based on the Phase 2 results as long as Phase 3 trial outcomes confirmed the results.
  • Only 40% of neurologists were initially aware of the FDA announcement regarding donanemab for Alzheimer's Disease (AD) when prompted.

BioArctic: New data on lecanemab presented at the 2024 AD/PD™ congress

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星期一, 三月 11, 2024
Diagnosis, Brain, Conference, Lecanemab, Disease, Incidence, Alpha-synuclein, Eisai, Patient, CAA, ARIA, DSM-IV codes, Antibody, Safety, Clarity, Pharmaceutical industry

BioArctic's founder, Professor Lars Lannfelt, presented data on the binding properties of the anti-amyloid-beta (Aβ) antibody lecanemab and other anti Aβ antibodies.

Key Points: 
  • BioArctic's founder, Professor Lars Lannfelt, presented data on the binding properties of the anti-amyloid-beta (Aβ) antibody lecanemab and other anti Aβ antibodies.
  • Lecanemab was designed to preferentially bind soluble (protofibrils), as well as insoluble Aβ aggregates (fibrils), to reduce both Aβ protofibrils and Aβ plaques in the brain.
  • The difference in binding to CAA[1] was presented, with lecanemab having lower binding to CAA than most other antibodies.
  • This could explain the difference in the adverse event ARIA[2] seen between different antibodies, with lecanemab showing relatively low incidence of ARIA.

Asceneuron Expands Scientific Advisory Board with World Leading Experts in Neurodegenerative Diseases

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星期三, 三月 6, 2024
Senior, Research, SAB, Lecanemab, Clinical Chemistry (journal), Neuroimaging, Lund University, University, Associate, Henrik, Key, School, OGA, Principal, Research and development, Queen Silvia of Sweden, Young, Brain, Therapy, Pharmacology, SAN, UCL, Geriatric psychiatry, Eric, Biomarker, Yale School of Medicine, ACTC, Sahlgrenska University Hospital, University College London, Division, Neurochemistry, FDA, Public health, Phase II, Neurology, Senior advisor, Executive Committee, Patient, Cognition, Yale school, European Grand Prix, Biogen, Pharmaceutical industry

LAUSANNE, Switzerland and SAN FRANCISCO, March 6, 2024 /PRNewswire/ -- Asceneuron SA, a clinical stage biotech company dedicated to targeting the root causes of neurodegenerative diseases, today announces the appointments of neurodegenerative disease experts to its Scientific Advisory Board (SAB).

Key Points: 
  • LAUSANNE, Switzerland and SAN FRANCISCO, March 6, 2024 /PRNewswire/ -- Asceneuron SA, a clinical stage biotech company dedicated to targeting the root causes of neurodegenerative diseases, today announces the appointments of neurodegenerative disease experts to its Scientific Advisory Board (SAB).
  • Asceneuron is advancing development of its lead asset ASN51 into Phase II clinical development targeting Alzheimer's disease.
  • The Scientific Advisory Board members have vast experience in clinical trial design and biomarkers and will help support this promising program through Phase II clinical development.
  • I am honored to have these stellar neurodegenerative experts join our SAB at a fundamental time of development.

Asceneuron Expands Scientific Advisory Board with World Leading Experts in Neurodegenerative Diseases

Retrieved on: 
星期三, 三月 6, 2024
Senior, Research, SAB, Lecanemab, Clinical Chemistry (journal), Neuroimaging, Lund University, University, Associate, Henrik, Key, School, OGA, Principal, Research and development, Queen Silvia of Sweden, Young, Brain, Therapy, Pharmacology, SAN, UCL, Geriatric psychiatry, Eric, Biomarker, Yale School of Medicine, ACTC, Sahlgrenska University Hospital, University College London, Division, Neurochemistry, FDA, Public health, Phase II, Neurology, Senior advisor, Executive Committee, Patient, Cognition, Yale school, European Grand Prix, Biogen, Pharmaceutical industry

LAUSANNE, Switzerland and SAN FRANCISCO, March 6, 2024 /PRNewswire/ -- Asceneuron SA, a clinical stage biotech company dedicated to targeting the root causes of neurodegenerative diseases, today announces the appointments of neurodegenerative disease experts to its Scientific Advisory Board (SAB).

Key Points: 
  • LAUSANNE, Switzerland and SAN FRANCISCO, March 6, 2024 /PRNewswire/ -- Asceneuron SA, a clinical stage biotech company dedicated to targeting the root causes of neurodegenerative diseases, today announces the appointments of neurodegenerative disease experts to its Scientific Advisory Board (SAB).
  • Asceneuron is advancing development of its lead asset ASN51 into Phase II clinical development targeting Alzheimer's disease.
  • The Scientific Advisory Board members have vast experience in clinical trial design and biomarkers and will help support this promising program through Phase II clinical development.
  • I am honored to have these stellar neurodegenerative experts join our SAB at a fundamental time of development.

BioArctic: Latest data on lecanemab to be presented at the 2024 AD/PD™ congress

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星期四, 二月 29, 2024
Lecanemab, Novel, Eisai, Conference, DSM-IV codes, Trial of the century, Clarity, Brain

In total, lecanemab will be featured in six presentations, including an oral presentation by BioArctic's founder Professor Lars Lannfelt.

Key Points: 
  • In total, lecanemab will be featured in six presentations, including an oral presentation by BioArctic's founder Professor Lars Lannfelt.
  • At AD/PD, BioArctic will present one oral presentation and one poster on lecanemab, both focused on the binding properties of lecanemab to various types of Aβ of lecanemab compared to several other Aβ antibodies.
  • In addition, the differences in the binding properties of multiple anti-amyloid (Aβ) antibodies to various types of Aβ and other data will be presented.
  • Lecanemab for the treatment of early Alzheimer's disease: the extension of efficacy results from Clarity AD

BioArctic: Latest data on lecanemab to be presented at the 2024 AD/PD™ congress

Retrieved on: 
星期四, 二月 29, 2024
AB, Lecanemab, Novel, Eisai, Conference, DSM-IV codes, Trial of the century, Clarity, Brain

In total, lecanemab will be featured in six presentations, including an oral presentation by BioArctic's founder Professor Lars Lannfelt.

Key Points: 
  • In total, lecanemab will be featured in six presentations, including an oral presentation by BioArctic's founder Professor Lars Lannfelt.
  • At AD/PD, BioArctic will present one oral presentation and one poster on lecanemab, both focused on the binding properties of lecanemab to various types of Aβ of lecanemab compared to several other Aβ antibodies.
  • In addition, the differences in the binding properties of multiple anti-amyloid (Aβ) antibodies to various types of Aβ and other data will be presented.
  • Lecanemab for the treatment of early Alzheimer's disease: the extension of efficacy results from Clarity AD

HKUST Neuroscientists Develop Highly Accurate Universal Diagnostic Blood Test for Alzheimer's Disease and Mild Cognitive Impairment

Retrieved on: 
星期一, 二月 19, 2024
Lecanemab, University College London, Hospital, Research, Pathology, Hope, Communication, Neurodegenerative disease, HKUST, Classification, Medicine, Patient, Journal, Protein, Disease, Diagnosis, MCI, Brain, Medical imaging

HONG KONG, Feb. 19, 2024 /PRNewswire/ -- An HKUST-led international research collaboration has achieved a significant milestone in Alzheimer's disease (AD) diagnosis and management. The team, spearheaded by Prof. Nancy IP, President and the Morningside Professor of Life Science at the Hong Kong University of Science and Technology (HKUST), and Director of the Hong Kong Center for Neurodegenerative Diseases (HKCeND), has developed a cutting-edge blood test for the early detection of AD and mild cognitive impairment (MCI), surpassing remarkable accuracy rates of over 96% and 87% respectively. Notably, this blood test is applicable across ethnic populations, providing a global solution to the diagnosis and management of AD.

Key Points: 
  • Notably, this blood test is applicable across ethnic populations, providing a global solution to the diagnosis and management of AD.
  • The recent approval of the AD drug Lecanemab offers new hope by targeting MCI or mild AD-related dementia with elevated Aβ in the brain.
  • Prof. Nancy IP and her team at HKUST have recently developed a blood test for the early detection of AD and MCI with exceptionally high accuracy.
  • These findings also highlight the applicability of the test across diverse ethnic and regional boundaries, showcasing its potential for global impact.

HKUST Neuroscientists Develop Highly Accurate Universal Diagnostic Blood Test for Alzheimer's Disease and Mild Cognitive Impairment

Retrieved on: 
星期一, 二月 19, 2024
Lecanemab, University College London, Hospital, Research, Pathology, Hope, Communication, Neurodegenerative disease, HKUST, Classification, Medicine, Patient, Journal, Protein, Disease, Diagnosis, MCI, Brain, Medical imaging

HONG KONG, Feb. 19, 2024 /PRNewswire/ -- An HKUST-led international research collaboration has achieved a significant milestone in Alzheimer's disease (AD) diagnosis and management. The team, spearheaded by Prof. Nancy IP, President and the Morningside Professor of Life Science at the Hong Kong University of Science and Technology (HKUST), and Director of the Hong Kong Center for Neurodegenerative Diseases (HKCeND), has developed a cutting-edge blood test for the early detection of AD and mild cognitive impairment (MCI), surpassing remarkable accuracy rates of over 96% and 87% respectively. Notably, this blood test is applicable across ethnic populations, providing a global solution to the diagnosis and management of AD.

Key Points: 
  • Notably, this blood test is applicable across ethnic populations, providing a global solution to the diagnosis and management of AD.
  • The recent approval of the AD drug Lecanemab offers new hope by targeting MCI or mild AD-related dementia with elevated Aβ in the brain.
  • Prof. Nancy IP and her team at HKUST have recently developed a blood test for the early detection of AD and MCI with exceptionally high accuracy.
  • These findings also highlight the applicability of the test across diverse ethnic and regional boundaries, showcasing its potential for global impact.