Novartis Reports Two Positive US Phase III Programs in COPD for QVA149, NVA237

Novartis announced today positive results from two pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). 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]. "These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life", said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "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". 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]. The safety profiles of QVA149, its monotherapy components and placebo were broadly similar across the EXPEDITION studies[6],[7], as was NVA237 to indacaterol and placebo in the GEM studies[8],[9]. There is an urgent need for new COPD treatments in the US as many people remain symptomatic despite receiving medical care[10]. Reflecting this, evidence from the EXPEDITION and GEM programs presented today has also been used to support current QVA149 and NVA237 US regulatory submissions.