[{"orgOrder":0,"company":"Kissei Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kissei announces the publication of the results of phase III clinical trials of rovatirelin for the treatment of spinocerebellar degeneration in the Journal of Neurology, Neurosurgery, and Psychiatry","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Kissei Pharmaceutical"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Results from the Second Phase III SAkuraStar Study for Chugai\u2019s Satralizumab in Neuromyelitis Optica Spectrum Disorder 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AB","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EISAI to Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State (DSE) Symposium, and Other Pipeline Assets At the AD\/PD\u2122 2022 Annual Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Eisai","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Latest Findings on Lecanemab - Clinical Efficacy, Aria Rates, Biomarkers Relationship To Clinical Outcomes And Dosing Regimens - Presented at AD\/PD\u2122 2022 Annual Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai Statement on the Centers for Medicare and Medicaid Services\u2019 National Coverage Determination With Coverage With Evidence Development for Monoclonal Antibodies Directed Against Amyloid for The Treatment of Alzheimer\u2019s Disease","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Eisai","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Long-term Health Outcomes Using Simulation Model of Investigational Lecanemab in Patients With Early Alzheimer\u2019s Disease Published in a Peer-reviewed Journal, Neurology and Therapy","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Eisai","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer\u2019s Disease Under the Accelerated Approval Pathway","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-initiated Clinical Trial of Ultrahigh-dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of Amyotrophic Lateral Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial Evaluating HYQVIA\u00ae for Maintenance Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Takeda Pharmaceutical"},{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai to Present the Latest Lecanemab Data, Including Aria-e and Subcutaneous Formulation, and Other Alzheimer's Disease Research at the Alzheimer's Association International Conference (AAIC) 2022","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"},{"orgOrder":0,"company":"Eisai","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lecanemab Confirmatory Phase 3 Clarity Ad Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction of Clinical Decline in Large Global Clinical Study of 1,795 Participants With Early Alzheimer\u2019s Disease","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Eisai"}]
Find Neurology Drugs in Phase III Clinical Development in JAPAN
BAN2401 (Lecanemab) treatment met primary endpoint and reduced clinical decline on global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents treatment difference score change of -0.45 in analysis of Intent-to-treat population.
BAN2401 (lecanemab) is an investigational humanized monoclonal antibody for Alzheimer's disease,selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD.
Data showed HYQVIA (immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), reduced relapse of neuromuscular disability and impairment when used maintenance therapy for CIDP, supporting its potential as fSCIG solution for many CIDP patients.
Mecobalamin (generic name, development code: E0302) is approved and marketed as Methycobal®, a 500 µg injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.
At 18 months of treatment, 10 mg/kg biweekly BAN2401(lecanemab) reduced brain amyloid by a mean of 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read.
An analysis of Study 761 suggested that ultrahigh-dose E0302 (methylcobalamin) prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset.
Article describes comparison of long-term clinical outcomes for people with early AD who have amyloid pathology with SoC alone, and with lecanemab with SoC, using disease simulation model based on results of a Phase IIb clinical trial evaluating efficacy, safety of lecanemab.
BAN2401 (lecanemab), is an antibody that binds to amyloid, which could reduce its presence in the brain and potentially slow the progress of patients with Alzheimer's disease, has met the Coverage with Evidence Development requirements with quality evidence.
Lecanemab, an investigational humanized mAB selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD.
BAN2401 (lecanemab) is an investigational humanized monoclonal antibody that selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD.
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