Verrica制药宣布FDA批准VP-102的新药申请,用于治疗感染性软疣

2019-11-28 Allan MedSci原创

医学皮肤病学公司Verrica近日宣布,FDA已经批准了VP-102的新药申请,用以治疗传染性软疣。Verrica总裁兼首席执行官Ted White表示:“目前,目前尚无FDA批准的治疗方法,如患者未经治疗,感染性软疣很容易传播,病变平均持续13个月”。

医学皮肤病学公司Verrica近日宣布,FDA已经批准了VP-102的新药申请,用以治疗传染性软疣。Verrica总裁兼首席执行官Ted White表示:目前,目前尚无FDA批准的治疗方法,如患者未经治疗,感染性软疣很容易传播,病变平均持续13个月

NDA基于两项III期随机、双盲、多中心临床试验(CAMP-1CAMP-2)的阳性结果,该试验评估了VP-102与安慰剂相比在两岁及以下患者中的安全性和有效性。CAMP-1是在FDASPA(特殊方案评估)下进行的。这两项试验均达到了完全清除感染性软疣的主要终点。


原始出处:

http://www.firstwordpharma.com/node/1683727#axzz66Wm9oxrD

本文系williamhill asia 医学(MedSci)原创编译整理,转载需授权!

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    2022-08-20 ms1000001792975531

    用什么药可以治呢

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    2020-09-25 charl1234575
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    2020-09-12 bugit

    #FDA批准#

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    2020-01-17 surilei

    #ERR#

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    2020-08-14 wangbingxhy

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