Novartis has announced positive results from several Phase 3 studies of NVA237 glycopyrronium bromide and QVA149 indacaterol/glycopyrronium bromide, both delivered by the Breezhaler DPI for the treatment of COPD. NVA237 is marketed as Seebri Breezhaler outside of the US, and QVA149 is marketed as Ultibro Breezhaler outside of the US.
According to the data presented at ATS 2015, both the EXPEDITION and GEM programs met their primary and secondary endpoints, with EXPEDITION demonstrating improvements in lung function and other parameters for patients using QVA149 compared to placebo and to monotherapy with its components over 12 weeks and GEM showing significant improvement in lung function for patients using NVA237 at the 12 week mark compared to placebo.
According to the company both programs also showed comparable safety for both inhalers compared to placebo and to monotherapy.
Novartis Global Head of Development Vasant Narasimhan said, “These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life. With millions of people in the US and around the world struggling to breathe due to COPD, Novartis is committed to advancing QVA149 and other new medicines to address this important unmet need.”
Read the Novartis press release.