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Harmony Biosciences的嗜睡症治疗药物Wakix获得FDA批准

2019-08-16 佚名 MedSci原创

HarmonyBiosciences嗜睡症WakixFDA批准
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美国食品和药物管理局批准Wakix/pitolisant治疗白天过度嗜睡的发作性嗜睡病成人患者。经过两年的准备之后，Harmony Biosciences准备首次推出该药物。首席执行官约翰雅各布斯表示，该公司在获得大约5亿美元融资后在过去两年内"从零开始"建立内部销售队伍，医学科学联络小组，市场准入团队等。在获得了FDA的批准以后，Harmony计划在第四季度推出该药物。至于这种药物，法国的Bio

美国食品和药物管理局批准Wakix/pitolisant治疗白天过度嗜睡的发作性嗜睡病成人患者。经过两年的准备之后，Harmony Biosciences准备首次推出该药物。

首席执行官约翰雅各布斯表示，该公司在获得大约5亿美元融资后在过去两年内"从零开始"建立内部销售队伍，医学科学联络小组，市场准入团队等。在获得了FDA的批准以后，Harmony计划在第四季度推出该药物。

至于这种药物，法国的Bioprojet开发了pitolisant并在2016年获得批准后在欧洲推出了药物。Harmony 在2017年秋季获得了美国对该药物的权利，并在当时筹集了2.7亿美元的股权融资。今年早些时候，Harmony 又获得了2亿美元的债务融资。

Harmony的首席医疗官Jeffrey Dayno表示，这种药物通过一种新的作用机制发挥作用，即增加大脑中组胺的合成和释放，并且是唯一被批准治疗该疾病的非受控药物。尽管已经存在几种嗜睡症药物选择，雅各布斯表示仍有一些未满足的需求，因为一些患者对他们的药物不满意或者不想服用预定的药物。

FDA根据来自261名患者的两项安慰剂对照研究的数据评估了Wakix的疗效。Harmony在2月份在FDA进行了优先审查。

原始出处：


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    2021-01-22 285714739

    学习了。感谢！

    0

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    2020-05-09 sunylz

    #Bio#

    0

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    2019-12-13 bugit

    #FDA批准#

    0

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    2020-07-25 周虎

    #治疗药物#

    0

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    2019-08-18 ms4468361851264128

    #AKI#

    0

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    2019-08-18 jichang

    #SCIE#

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