Mylan与Theravance制药的Yupelri被FDA批准用于COPD

2018-11-11 MedSci MedSci原创

Mylan和Theravance制药近日(2018年11月9日)宣布,FDA已经正式批准Yupelri(revefenacin)作为慢性阻塞性肺病(COPD)患者的维持治疗药物。COPD是阻塞性肺病的一种,主要表现为持续性的气流受限,症状包括呼吸短促、咳嗽等。

MylanTheravance制药近日(2018119日)宣布,FDA已经正式批准Yupelrirevefenacin)作为慢性阻塞性肺病(COPD)患者的维持治疗药物。COPD是阻塞性肺病的一种,主要表现为持续性的气流受限,症状包括呼吸短促、咳嗽等。

该公司预计将在今年年底前推出这种药物,该公司表示,Yupelri是在美国推出的首例长效毒蕈碱拮抗剂(LAMA),以雾化形式达到扩张支气管的目的(每日一次)。在2016年公布的两项III期研究中,与安慰剂相比,Yupelri在治疗12周后显示出在1秒内显著改善用力呼气量的能力。Mylan总裁Rajiv Malik指出:“YupelriCOPD患者提供了雾化的LAMA治疗,可改善COPD患者的24小时肺功能,并可通过任何标准喷射雾化器提供每日一次的便利给药Baird分析师Brian Skorney评论了这一消息,他估计Yupelri可能在2030年实现超过2.5亿美元的销售额,并表示雾化的Yupelri相对受限于COPD的治疗范例,因此联合治疗将是主流。


原始出处:

http://www.firstwordpharma.com/node/1603553#axzz5WX3s5ws8

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    2019-05-27 feather89
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    2019-09-11 haouestc
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    2018-11-13 tidiq