Phase III Study of QVA 149 (Novartis) for COPD meets primary endpoint and clarifies timing of US filings

New data on ILLUMINATE, a head-to-head Phase III study of QVA 149 (indacaterol plus glycopyrronium bromide), from Novartis, compared to Seretide(fluticasone plus salmeterol), shows the drug has met its primary endpoint in patients with moderate to severe Chronic Obstructive Pulmonary Disease. The ILLUMINATE study of more than 500 patients demonstrated that superior lung function (measured by FEV1 AUC0-12h with a p value <0.001) was achieved with once-daily qva 149 compared with twice-daily seretide. this study is an important part of the regulatory submission for qva 149 and after discussions with the fda, novartis has confirmed an agreed phase iii trial design for qva 149 and expect filing to the fda at the end of 2014.>