FDA批准Dermira的Qbrexza治疗原发性腋窝多汗症

2018-06-30 MedSci MedSci原创

Dermira本周五宣布,FDA批准了Qbrexza(glycopyrronium)用于局部治疗9岁及以上成人和儿童患者的原发性腋窝多汗症。该公司指出,该产品预计将于10月开始供货。

外泌汗腺位于真皮内,主要受胆碱能神经分泌乙酰胆碱递质支配,分泌物以水为主。很多患者在睡觉、休息、放松等交感神经不兴奋时则是不出汗的,一运动或者紧张等交感神经兴奋时,其功能亢进,就会分泌出很多的汗液,我们称之为多汗症。顶泌汗腺主要位于皮下浅层,紧邻真皮,其除了受胆碱能神经支配外,还受其它肾上腺素能神经支配,主要分泌一些不饱和或羟基化的支链脂肪酸,这些物质被分泌至皮肤表面,被细菌分解后可具有特殊气味,严重的时候可影响到人们的生活和日常交往。Dermira本周五宣布,FDA批准了Qbrexzaglycopyrronium)用于局部治疗9岁及以上成人和儿童患者的原发性腋窝多汗症。该公司指出,该产品预计将于10月开始供货。

去年11月,美国食品药品监督管理局(FDA)接受了Dermira提交的治疗方案,得到了III临床试验ATMOS-1ATMOS-2研究的有效性和安全性数据的支持。在2016年公布的研究数据中,该治疗与出汗严重程度的显著改善相关。Cantor Fitzgerald分析师Louise Chen表示,Qbrexza获得了广泛的好评。分析师预测,到2023年,Qbrexza销售额将达到2.5亿至3亿美元。


原始出处:

http://www.firstwordpharma.com/node/1575652#axzz5JsCRXxz0

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    2018-08-10 smallant2002