Novartis has announced that it submitted New Drug Applications to the FDA for both the QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide DPIs in the fourth quarter of 2014. Both inhalers are meant for the treatment of COPD. In early 2012, the company said that it planned to submit marketing applications for the two products in the US by the end of 2014.
QVA149 was approved in Japan and in the EU in September 2013, and it is marketed in over 50 countries as Ultibro Breezhaler. NVA237 was approved in Japan a year earlier and in Europe in October 2012; it is marketed in more than 70 countries as Seebri Breezhaler.
The company also announced results from Phase 3 clinical trials of both DPIs, which met both primary and secondary endpoints.
Novartis Global Head of Development Vasant Narasimhan commented, “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.”
Read the Novartis press release.
