Novartis Trial Shows Dual Bronchodilator Significantly Improved Lung Function in COPD Patients Compared to Single Bronchodilators

Novartis AG (NYSE:NVS) announced the detailed results from its Phase III trial programs for QVA149 (indacaterol/glycopyrronium) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), which showed significant improved lung function for dual bronchodilator, compared to single bronchodilators.

As quoted in the press release:

The EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM programs met their primary and secondary endpoints, and the results were presented for the first time at the ATS International Conference, May 15-20, 2015, in Denver, US[1]-[9].

Data from the EXPEDITION program demonstrated that QVA149, administered twice-daily, improved lung function (FEV1 AUC0-12h) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, meeting its primary objective[1]-[2]. Further findings also confirmed that Novartis’ dual bronchodilator improved breathlessness, overall quality of life and COPD rescue medication use[1]-[4]. It also showed significant improvements in FEV1 at 5 min and 15 min compared to placebo according to new pooled data from over 2,000 patients[5].

In the GEM 1 and 2 studies, NVA237, administered twice-daily, demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo (p<0.001); meeting its primary objective[8],[9]. Improvements in COPD symptoms, quality of life and rescue medication use in patients with moderate-to-severe airflow limitation were also observed[8],[9].

Vasant Narasimhan, head of development at Novartis Pharmaceuticals, commented:

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.

Click here to read the full Novartis AG (NYSE:NVS) press release.