Associated tags: Neurology, Patient, Health, Anxiety, Pharmaceutical industry, Eisai, Biogen, Clarity, AD, Co-promotion, Alzheimer's disease, Disease, Lecanemab, BIIB, The New England Journal of Medicine, Brain
TOKYO and CAMBRIDGE, Mass., July 19, 2023 (GLOBE NEWSWIRE) -- 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.
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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.
TOKYO and CAMBRIDGE, Mass., July 6, 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 U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease (AD). LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (MCI) due to AD or mild AD. 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:
- "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.
- "Alzheimer's disease is a progressive, fatal disease that greatly impacts not only the people living with it, but also their loved ones, care partners and society.
- We continue to work to create broad and simple access to LEQEMBI for patients and to support diagnosis and treatment at the early stage of the disease.
- On January 6, 2023, LEQEMBI was approved by the FDA under the accelerated approval pathway.
TOKYO and CAMBRIDGE, Mass., July 06, 2023 (GLOBE NEWSWIRE) -- 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 U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (MCI) due to AD or mild AD. 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:
- “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.
- “Alzheimer’s disease is a progressive, fatal disease that greatly impacts not only the people living with it, but also their loved ones, care partners and society.
- We continue to work to create broad and simple access to LEQEMBI for patients and to support diagnosis and treatment at the early stage of the disease.
- On January 6, 2023, LEQEMBI was approved by the FDA under the accelerated approval pathway.
Priority review,
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Health Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
Key Points:
- Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
- As such, lecanemab may have the potential to have an effect on disease pathology and to slow down 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.
- Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.
Priority review,
The New England Journal of Medicine,
Plaque,
NDS,
MHLW,
Marketing,
Neurotoxicity,
Food,
Advisory Committee,
European Medicines Agency,
Medicines and Healthcare products Regulatory Agency,
Lecanemab,
BIIB,
Ministry of Health, Labour and Welfare,
Brain,
Pharmaceuticals and Medical Devices Agency,
Medication,
Oncology Drug Advisory Committee,
EMA,
Clarity,
Ministry,
The Different Forms of Flowers on Plants of the Same Species,
Eisai,
Prescription Drug User Fee Act,
Headquarters,
PMDA,
National Medical Products Administration,
Corporation,
Co-promotion,
PDUFA,
Ministry of Health (Kuwait),
MAA,
AD,
FDA,
Phase,
Health Canada,
BLA,
NMPA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Disease,
Pharmaceutical industry,
Biogen,
Health Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
Key Points:
- Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
- As such, lecanemab may have the potential to have an effect on disease pathology and to slow down 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.
- Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.
Apolipoprotein E,
Alzheimer's disease,
Lecanemab,
BIIB,
PET,
Horseshoe kidney,
Cmax,
Biomarker,
MCI,
Plasma,
Eisai,
Incidence,
ARIA,
ARIA-H,
Amyloid,
Amyloid-related imaging abnormalities,
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ADAS,
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AD,
Phase,
OLE,
Safety,
Pharmaceutical industry,
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Biogen,
Dementia Consistency of efficacy results across various clinical measures and statistical methods in Study 201: Alzheimer's Research and Therapy
Key Points:
- Consistency of efficacy results across various clinical measures and statistical methods in Study 201: Alzheimer's Research and Therapy
3.
- ARIA (amyloid-related imaging abnormality) profile in Study 201: Alzheimer's & Dementia: Translational Research and Clinical Interventions
Study 201 was a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD.
- ARIA-H events in the OLE were generally consistent with the rate seen in the lecanemab 10 mg/kg biweekly group in the core study.
- Based on the fact that lecanemab was generally well tolerated at the highest dose in this study, the Phase 3 Clarity AD study was conducted without dose titration.
Amyloid-related imaging abnormalities,
Anticoagulant,
Apolipoprotein E,
Intracerebral hemorrhage,
Disease,
Alzheimer's disease,
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The New England Journal of Medicine,
Overalls,
BIIB,
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Horseshoe kidney,
Siderosis,
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ARIA-H,
The Different Forms of Flowers on Plants of the Same Species,
Incidence,
QOL,
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Clarity,
Eisai Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
Key Points:
- Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
- Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer's Disease
In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
- In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
- The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.
Amyloid-related imaging abnormalities,
Anticoagulant,
Apolipoprotein E,
Intracerebral hemorrhage,
Alzheimer's disease,
Clinical trial,
The New England Journal of Medicine,
Overalls,
Edema,
BIIB,
Quality of life,
Horseshoe kidney,
Siderosis,
Quality,
ARIA-H,
The Different Forms of Flowers on Plants of the Same Species,
Eisai,
QOL,
Incidence,
Dementia,
ARIA,
International Conference on Population and Development,
Patient,
Headquarters,
Randomness,
Corporation,
Quality of life (healthcare),
Co-promotion,
Caregiver burden,
Conference,
Pharmaceutical industry,
Biogen,
Lecanemab,
Clarity Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
Key Points:
- Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
- Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer’s Disease
In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
- In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
- The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.
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.
