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
Retrieved on:
Wednesday, October 25, 2023
TOKYO and CAMBRIDGE, England, Oct. 25, 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 Eisai presented new data for LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous (IV) use, in the Late Breaking Symposium 4 "Lecanemab for Early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration" at the 16th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference held in Boston, Massachusetts, United States and virtually October 24-27, 2023.
Key Points:
- 1
Eisai aims to submit a LEQEMBI SC formulation Biologics License Application (BLA) with the U.S. Food and Drug Administration by March 31, 2024.
- The low-tau subpopulation, which is in the earlier stages of early AD, is thought to show slow disease progression.
- This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety.
- There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
Retrieved on:
Wednesday, October 25, 2023
TOKYO and CAMBRIDGE, Mass., Oct. 25, 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 Eisai presented new data for LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous (IV) use, in the Late Breaking Symposium 4 "Lecanemab for Early Alzheimer's Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration" at the 16th annual Clinical Trials on Alzheimer's Disease (CTAD) conference held in Boston, Massachusetts, United States and virtually October 24-27, 2023.
Key Points:
- 1
Eisai aims to submit a LEQEMBI SC formulation Biologics License Application (BLA) with the U.S. Food and Drug Administration by March 31, 2024.
- The low-tau subpopulation, which is in the earlier stages of early AD, is thought to show slow disease progression.
- In the Clarity AD Tau PET substudy, LEQEMBI treatment slowed the buildup of tau proteins in the temporal lobe (early Braak region), where tau accumulation was observed in the earlier stage of early AD.
- This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety.
Retrieved on:
Monday, September 25, 2023
Hypersensitivity,
Status epilepticus,
Intracerebral hemorrhage,
Cerebral amyloid angiopathy,
Arthralgia,
Cerebral edema,
Hypotension,
Aneurysm,
Risk,
Focal neurologic signs,
Chills,
Fatal,
Fever,
Edema,
Neuroimaging,
AND,
Angioedema,
Siderosis,
Tissue plasminogen activator,
Aspirin,
Hypertension,
Vomiting,
Incidence,
Excipient,
ARIA,
Anticoagulant,
MRI,
Magnetic resonance imaging,
Dizziness,
Amyloid,
Patient,
Intraparenchymal hemorrhage,
Anaphylaxis,
Paracetamol,
Seizure,
Genetic testing,
Confusion,
Nausea,
Observation,
Lecanemab,
Headache,
Bronchospasm,
Vascular malformation,
Medical device,
Pharmaceutical industry,
Lace,
Medical imaging,
Copper INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.
Key Points:
- INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.
LEQEMBI is indicated for the treatment of Alzheimer’s disease.
- 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.
- ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.
- Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
Retrieved on:
Monday, September 25, 2023
Amyloid-related imaging abnormalities,
PMID,
Outline,
Clinical trial,
Marketing,
The New England Journal of Medicine,
Deficit spending,
Pathology,
Ministry of Health, Labour and Welfare,
Research,
Brain,
Siderosis,
History,
MCI,
The Different Forms of Flowers on Plants of the Same Species,
Clarity,
Ministry,
ARIA,
Dementia,
HIV disease progression rates,
Patient,
Immunoglobulin G,
Superficial siderosis,
PLOS One,
Co-promotion,
Ministry of Health (Kuwait),
Therapy,
Headache,
Neurotoxicity,
Disease,
ADCS,
Pharmaceutical industry,
Alzheimer's disease,
Biogen,
Amyloid beta,
Health,
Eisai Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.
Key Points:
- Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.
- In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.
- "Today LEQEMBI received approval, making it the first 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 in Japan.
- In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.
Retrieved on:
Thursday, September 21, 2023
TOKYO, Sept 21, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today on World Alzheimer's Day, that it has released a dementia awareness video, "Life Goes On 2023: Two Memories, One Story", on its dementia information website "Sodan.e-65" and YouTube, which are intended to deepen the understanding of dementia.
Key Points:
- TOKYO, Sept 21, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today on World Alzheimer's Day, that it has released a dementia awareness video, "Life Goes On 2023: Two Memories, One Story", on its dementia information website "Sodan.e-65" and YouTube, which are intended to deepen the understanding of dementia.
- With the rapidly aging population, it is predicted that by 2025, one in five people over the age of 65 in Japan will have dementia,(1) and dementia is now something that is familiar to everyone.
- A story of a couple and their family accepting life with dementia and moving forward.
- Eisai will continue to contribute to realize a Dementia Inclusive Society where no one is left behind through creating social impact by building a dementia ecosystem via collaboration with local governments and other industries.
Retrieved on:
Tuesday, September 12, 2023
Communication,
Personal health record,
MCI,
ADL,
Trial of the century,
Dementia,
Algorithm,
PHR,
Ecosystem,
Caregiver,
Disease,
Residential care,
Eisai,
Christian mysticism TOKYO, Sept 12, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has established a digital business company Theoria technologies Co., Ltd. ("Theoria technologies") which will accelerate the development of a dementia ecosystem.
Key Points:
- TOKYO, Sept 12, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has established a digital business company Theoria technologies Co., Ltd. ("Theoria technologies") which will accelerate the development of a dementia ecosystem.
- Theoria technologies is a wholly owned subsidiary of Eisai.
- In addition, together with Eisai, Theoria technologies will develop and provide Sasaeru, an application that helps facilitate communication between people with dementia, doctors, and caregivers by recording Activities of Daily Living (ADL) of the people with dementia.
- Furthermore, Theoria technologies will promote the development of digital services by strengthening collaboration with other companies.
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.
Its continued approval may be contingent upon verification of LEQEMBI's clinical benefit in the confirmatory Clarity AD trial (Study 301).
Key Points:
- Its continued approval may be contingent upon verification of LEQEMBI's clinical benefit in the confirmatory Clarity AD trial (Study 301).
- The advisory committee agreed unanimously that Study 301 verified the clinical benefit.
- 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.
- Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
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.
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.
