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    Home > Medical News > Latest Medical News > The first batch in the world!

    The first batch in the world!

    • Last Update: 2021-11-16
    • Source: Internet
    • Author: User
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    Article source: Medical Rubik's Cube Info

    On September 27, ChemoCentryx, Vifor Pharma, and Kissei Pharmaceutical jointly announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved the first-in-class oral small molecule complement C5a receptor inhibitor Tavneos (avacopan) to be marketed
    .
    It is used to treat two main types of anti-neutrophil cytoplasmic autoantibody (ANCA)-related vasculitis: microscopic polyangiitis (MPA) and granuloma with polyangiitis (GPA)

    .
    This is the first time this C5aR inhibitor has been approved globally

    .

    ANCA-related vasculitis is a systemic disease.
    Excessive activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels, causing damage and failure of organs such as kidneys

    .
    At present, the treatment of this disease includes non-specific immunosuppressant (cyclophosphamide or rituximab) treatment and long-term daily daily glucocorticoid (steroid), which may cause major clinical risks, including death from infection

    .

    Avacopan uses a novel and highly targeted mechanism of action in the treatment of ANCA-related vasculitis and other complement-driven autoimmune and inflammatory diseases
    .
    It avoids upstream complement inhibition, does not hinder the production of C5b-9, retains the body's defense mechanism (MAC), and also retains the beneficial functions of the C5L2 pathway

    .

    On July 6 this year, ChemoCentryx announced that the PDUFA target date for avacopan's new drug application in the United States has been extended to October 7, 2021
    .
    The PDUFA date for avacopan NDA application was originally July 7, 2021

    .

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