制药巨人Novartis公司研制的用于治疗慢性阻塞性肺炎的新药Ultibro Breezhaler获得欧洲人类用药管理委员会（European Committee for Medicinal Products for Human Use）审批通过。该药物的主要成分是Indacaterol--一种肾上腺素阻遏剂--和Glycopyrronium Bromide，一种抗胆碱能剂组成。
Swiss pharma giant Novartis ($NVS) has earned an endorsement from the European Committee for Medicinal Products for Human Use (CHMP) for its once-daily Ultibro Breezhaler to treat chronic obstructive pulmonary disease. The nod was one of 8 new CHMP-recommended medicines for approval this week.
Novartis' Xoterna Breezhaler--known as QVA149 in clinical trials--received a positive opinion from the committee for COPD, a group of lung diseases that includes emphysema, chronic bronchitis, and, in some cases, asthma. According to the Centers for Disease Control and Prevention (CDC), COPD was the third-leading cause of death in the U.S. in 2011.
Ultibro Breezhaler is a fixed-dose combination of Indacaterol, a beta-2-adrenergic agonist, and Glycopyrronium Bromide, an anticholinergic. Indacaterol works by causing the muscles of the airways to relax, while glycopyrronium helps to dilate the airways. In clinical trials, the inhaler improved lung function and reduced flare-ups. A U.S. filing is expected at the end of 2014. The CHMP also gave a positive recommendation for Novartis' Xoterna Breezhaler.
Following an FDA approval earlier this month for Boehringer Ingelheim's Giotrif (afatinib), the targeted therapy for non-small cell lung cancer also scooped up a recommendation by CHMP this week.
The CHMP also recommended marketing authorizations for Takeda Pharmaceuticals' Incresync, Vipdomet and Vipidia for the treatment of Type 2 diabetes, Gilead Sciences' ($GILD) Tybost for HIV, and Apotex Europe's Grastofil for neutropenia, a condition of an abnormally low number of white blood cells.
Japaense drugmaker Otsuka's treatment delamanid for multi-drug resistant tuberculosis received a negative opinion from the committee, which expressed concern that the duration of treatment in the main study was too short to determine the effectiveness of the therapy.
The European Commission typically endorses CHMP's recommendations for marketing approval within a couple of months.
我的社区
签到
赛默飞实验室产品焕新计划有奖调研！
【七月征文】不一YOUNG实验“猿”
报名开启：ICS2024第十三届光谱网络会议！
推荐收藏！盘点中药材及饮片检测解决方案
