Novartis announced today positive top-line results from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support New Drug Applications (NDAs) with the US Food and Drug Administration (FDA) for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM clinical trial programs met their primary and secondary endpoints. 

COPD symptoms can negatively impact a patient's ability to breathe and perform essential daily activities, thereby reducing their quality of life. There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy.

"These data once again confirm the strong efficacy and favourable safety profiles of both QVA149 and NVA237," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "With submissions to the US FDA now complete for both treatments, we are closer to offering US patients with COPD a broader range of treatment options to help improve the significant burden of reduced lung function, and to help improve their lives."

For more details, go to: http://www.novartis.com/newsroom/media-releases/en/2015/1885149.shtml