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    Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor
    2.
    发明授权
    Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor 有权

    公开(公告)号：US11031102B2

    公开(公告)日：2021-06-08

    申请号：US14941080

    申请日：2015-11-13

    申请人： Alexion Pharmaceuticals, Inc.

    发明人： Leonard Bell ,  Camille Bedrosian

    IPC分类号： G01N33/48 ,  G16H10/20 ,  G16H10/60 ,  G16H15/00 ,  G16H20/10 ,  G06G7/58 ,  G16H40/67

    摘要： This invention provides, inter alia, a complement-inhibitor-based treatment plan coupled with a risk evaluation and management strategy (“REMS”) and a safety support program (“SSP”) for reinforcing the REMS. The REMS and SPP are implemented using one or more computer devices with software tools programmed to enforce conditions of the REMS and/or prompt follow-ups by registered nurses enrolled in the SSP. The software tool(s) determines whether a prescriber requesting the complement inhibitor has agreed to abide by the REMS, and can prompt a provider of the complement inhibitor to provide updated educational materials to the prescriber at predetermined times or intervals, to monitor the prescriber for compliance with the REMS, and/or to monitor patients for signs of adverse events. Using exemplary embodiments described herein, a risk of adverse events (especially, but not limited to, meningococcal infections) can be managed and an incidence of the adverse events can be reduced.

    METHODS AND COMPOSITIONS FOR TREATING COMPLEMENT-ASSOCIATED DISORDERS
    6.
    发明申请
    METHODS AND COMPOSITIONS FOR TREATING COMPLEMENT-ASSOCIATED DISORDERS 审中-公开
    治疗补体相关疾病的方法和组合

    公开(公告)号：US20160319004A1

    公开(公告)日：2016-11-03

    申请号：US15148491

    申请日：2016-05-06

    申请人： Alexion Pharmaceuticals, Inc.

    发明人： Russell P. Rother ,  Camille Bedrosian ,  Stephen P. Squinto ,  Leonard Bell

    IPC分类号： C07K16/18 ,  A61K9/00 ,  A61K39/395 ,  A61K45/06

    CPC分类号： C07K16/18 ,  A61K9/0019 ,  A61K38/00 ,  A61K39/3955 ,  A61K45/06 ,  A61K2039/505 ,  A61K2039/54 ,  A61K2039/545 ,  C07K2317/24 ,  C07K2317/34

    摘要： The present disclosure relates to, inter alia, compositions containing an inhibitor of human complement and use of the compositions in methods for treating or preventing complement-associated disorders. In some embodiments, the inhibitor is chronically administered to patients. In some embodiments, the inhibitor is administered to a patient in an amount and with a frequency to maintain systemic complement inhibition and prevent breakthrough. In some embodiments, the compositions contain an antibody, or antigen-binding fragment thereof, that binds to a human complement component C5 protein or a fragment of the protein such as C5a or C5b.

    摘要翻译： 本公开尤其涉及包含人补体抑制剂的组合物和组合物在治疗或预防补体相关疾病的方法中的用途。 在一些实施方案中，将抑制剂长期施用于患者。 在一些实施方案中，抑制剂以一定量和频率施用于患者以维持系统性补体抑制并防止突破。 在一些实施方案中，组合物含有结合人补体成分C5蛋白或蛋白质片段如C5a或C5b的抗体或其抗原结合片段。

    Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor
    8.
    发明授权
    Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor 有权

    公开(公告)号：US11244744B2

    公开(公告)日：2022-02-08

    申请号：US15614964

    申请日：2017-06-06

    申请人： Alexion Pharmaceuticals, Inc.

    发明人： Leonard Bell ,  Camille Bedrosian

    IPC分类号： G01N33/48 ,  G16H10/20 ,  G16H10/60 ,  G16H15/00 ,  G16H20/10 ,  G06G7/58 ,  G16H40/67

    摘要： This invention provides, inter alia, a complement-inhibitor-based treatment plan coupled with a risk evaluation and management strategy (“REMS”) and a safety support program (“SSP”) for reinforcing the REMS. The REMS and SPP are implemented using one or more computer devices with software tools programmed to enforce conditions of the REMS and/or prompt follow-ups by registered nurses enrolled in the SSP. The software tool(s) determines whether a prescriber requesting the complement inhibitor has agreed to abide by the REMS, and can prompt a provider of the complement inhibitor to provide updated educational materials to the prescriber at predetermined times or intervals, to monitor the prescriber for compliance with the REMS, and/or to monitor patients for signs of adverse events. Using exemplary embodiments described herein, a risk of adverse events (especially, but not limited to, meningococcal infections) can be managed and an incidence of the adverse events can be reduced.