Positive data on QVA 149 (Novartis) from three Phase III studies of COPD - 05-Sep-2012

Three new studies of QVA 149 (indacaterol plus glycopyrronium bromide), from Novartis, in the IGNITE Phase III trial program demonstrate the drug significantly improves lung function compared to other COPD therapies. SHINE met its primary endpoint by demonstrating that once-daily QVA 149 improved lung function as measured by trough FEV1 compared to once-daily indacaterol maleate and once-daily glycopyrronium. It was also more effective at improving lung function compared to OL tiotropium and placebo. Results also showed that QVA 149 improved breathlessness, measured by the transition dyspnea index, increased health-related quality of life and reduced rescue medication use.

ILLUMINATE compared QVA 149 to the twice-daily LABA/ICS salmeterol/fluticasone over 26 weeks in patients with COPD. The study met its primary endpoint by demonstrating that the mean FEV1 area under the curve for 0-12hr at Week 26 was significantly higher with QVA 149 compared to salmeterol/fluticasone. It also demonstrated that QVA 149, in comparison to salmeterol/fluticasone significantly improved breathlessness measured by TDI and reduced rescue medication use.

Finally ENLIGHTEN demonstrated the efficacy of QVA 149 at improving lung function over a 52-week period by showing that the drug increased FEV1 and forced vital capacity (FVC) versus placebo. QVA 149 was generally well tolerated. Results were presented at the European Respiratory Society Congress.