Novartis治疗COPD新药获得欧盟批准

详细英文报道：

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.