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Levo Therapeutics的鼻内卡贝缩宫素治疗Prader-Willi综合症,获得FDA的快速通道指定

2019-11-22 不详 MedSci原创

Levo Therapeutics的LV-101(鼻内卡贝缩宫素)获得美国食品和药物管理局(FDA)的快速通道指定,用于治疗Prader-Willi综合症(PWS)。

Levo Therapeutics的LV-101(鼻内卡贝缩宫素)获得美国食品和药物管理局(FDA)的快速通道指定,用于治疗Prader-Willi综合症(PWS)。

PWS又称肌张力低下-智能障碍-性腺发育滞后-肥胖综合症、普拉德-威利综合症,俗称小胖威利综合症,是一种罕见的遗传性疾病。该疾病在病程不同时期有着不同的症状与体征。在新生儿期,患儿会出现喂养困难、生长缓慢等症状;自2岁左右起,则会陆续出现过度摄食从而导致严重肥胖、生长落后以及代谢紊乱,如高发糖尿病。此外,亦可出现行为方式上的异常。

Levo Therapeutics首席执行官Sara Cotter说:"我们很高兴获得FDA的快速通道认证,该指定将促进我们对PWS疾病的理解。"

Levo目前正在美国和加拿大的20多个临床研究中心招募参与鼻内carbetocin治疗PWS的III期临床研究(称为CARE-PWS)的参与者。

"Levo致力于为PWS患者开发有影响力的治疗方法,我们的III期研究旨在观察鼻内carbetocin是否具有这样的治疗潜力。" Cotter继续说道,"期待在接下来的几个月中完成这项重要临床研究的注册。"

药物开发作为单独或与多种其他药物组合治疗严重或危及生命的疾病,并证明有潜力解决对疾病未满足的医疗需求时,FDA可以将该药物指定为快速通道产品。

原始出处:


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    2020-02-24 Boyinsh
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    2020-04-03 feather89
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    2019-11-23 14794e5bm67(暂无昵称)

    非常好的研究,学习了

    0

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