Novartis announces robust Phase III results for QVA149 and NVA237 and submits regulatory applications to US FDA - Seite 2

In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV₁ AUC_0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo; meeting its primary objective[4,5,9]. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies[4,5]. Data from the EXPEDITION and GEM programs are expected to be presented at major medical congresses later this year.

About EXPEDITION 
The EXPEDITION Program consisted of studies, including FLIGHT 1 and 2, which were identical 12-week, multi-center, randomized, double blind, parallel-group, placebo and active controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare twice-daily QVA149 27.5/12.5 mcg to its monotherapy components  in terms of lung function (FEV₁ AUC_0-12h) at Week 12[1,2].

FLIGHT 3 was a 52-week randomized double blind, parallel-group study to assess the safety and tolerability of twice-daily QVA149 27.5/12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study[3].

About GEM
GEM 1 and 2 were 12-week multi-center, randomized, double-blind, placebo controlled studies to assess the efficacy and safety of twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg in moderate-to-severe COPD patients. The primary objective was to compare twice-daily NVA237 to placebo in terms of lung function (FEV₁ AUC_0-12h) after 12 weeks of treatment[4,5]. The objective of GEM 3 was to determine safety and tolerability of twice-daily NVA237 12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients.

About QVA149
Twice-daily QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, as used in the EXPEDITION program, is being submitted for US registration only. Outside of the US, QVA149 has been developed/marketed as Ultibro Breezhaler 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD[10]. Once-daily Ultibro® Breezhaler® is currently approved for use in over 50 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.