Novartis reports top-line results in COPD trials; NDA acceptance will trigger milestone for Vectura

Swiss drug major Novartis (NOVN: VX) today announced positive top-line results from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/ glycopyrronium bromide) and NVA237 (glycopyrronium bromide).

The results will support New Drug Applications with the US Food and Drug Administration 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.

Vasant Narasimhan, global head of development, Novartis Pharmaceuticals, said: “These data once again confirm the strong efficacy and favorable safety profiles of both QVA149 and NVA237. 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.”