Novartis reports positive Phase III results for QVA149 and NVA237

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."

The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients.

Improvements in overall health status, a secondary endpoint based on the St George’s Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 12. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies.

In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) 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. Data from the EXPEDITION and GEM programs are expected to be presented at major medical congresses later this year.

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 AUC0-12h) at Week 12.

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.

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 AUC0-12h) after 12 weeks of treatment. 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.

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.

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.