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    Home > Medical News > Latest Medical News > The label restrictions are settled!

    The label restrictions are settled!

    • Last Update: 2021-12-27
    • Source: Internet
    • Author: User
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    On December 15, 2021, Eastern Time, the FDA approved AbbVie's Rinvoq for the treatment of psoriatic arthritis, and also approved Pfizer's Xeljanz for the treatment of active ankylosing spondylitis

    The delayed approval of the application for the treatment of inflammatory diseases occurred after the FDA completed the safety risk review and labeling restrictions of oral JAK inhibitor drugs

    The limitations of these labels are not surprising

    The extra caution for JAK inhibitor drugs stems from a post-marketing study by Xeljanz

    The approval of Rinvoq's new psoriatic arthritis is based on two phase III trials

    Psoriatic arthritis and ankylosing spondylitis are relatively minor indications for JAK drugs

    In contrast, atopic dermatitis is a major indication observed by industry analysts

    For rheumatoid arthritis and psoriatic arthritis, Rinvoq is only used in a dose of 15 mg

    But Porges is not sure whether AbbVie can obtain approval for the high-dose Rinvoq for the treatment of eczema

    Reference source: AbbVie's Rinvoq, Pfizer's Xeljanz win new uses after extended reviews as JAK safety woes linger

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