Novartis files QVA 149 in EU for COPD

QVA 149 (indacaterol plus glycopyrronium bromide), an investigational drug from Novartis, for Chronic Obstructive Pulmonary Disease (COPD) has been filed for marketing authorisation with the EMA. The first five studies in the Phase III IGNITE clinical trial program for QVA 149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 area under the curve for 0-12 hours at 26 weeks versus salmeterol/fluticasone, mean trough FEV1 at 26 weeks versus both indacaterol maleate and glycopyrronium bromide, reduction in the rate of exacerbations versus glycopyrronium bromide, and exercise endurance time at 21 days versus placebo. The data from ENLIGHTEN demonstrated that QVA 149 has a similar overall adverse event profile to placebo. Further filings for regulatory approval are expected in Q4 2012 for Japan and at the end of 2014 for the US.