QVA149 meets COPD endpoint in fifth Phase III trial

Novartis AG (NYSE:NVS; SIX:NOVN) said once-daily QVA149 met the primary endpoint of reducing the rate of moderate to severe exacerbations from baseline to week 64 vs. NVA237 in the Phase III SPARK trial to treat chronic obstructive pulmonary disease (COPD). QVA149 missed the secondary endpoint of reducing the rate of moderate to severe exacerbations compared to open-label tiotropium, but did significantly reduce the overall rate of all exacerbations compared to both NVA237 (p=0.001) and tiotropium (p=0.002). The adverse event profile of QVA149 was similar to that of both NVA237 and tiotropium. The trial, which enrolled 2,224 patients with severe to very severe COPD, is part of the 10-trial Phase III IGNITE program of QVA149. Including SPARK, QVA149 has now met the primary endpoint in five of the trials. Three more IGNITE trials are expected to complete by year end.

QVA149 is a fixed-dose combination of NVA237, an inhaled LAMA, and Novartis' indacaterol, a LABA marketed in more than 60 countries, including the U.S. and those of the EU, for COPD. Novartis plans to submit regulatory applications for QVA149 in Europe and Japan in 4Q12, while a U.S. submission is slated for year end 2014. NVA237 is under review in Europe and Japan, where it is known as Seebri Breezhaler, while Novartis plans to submit an NDA to FDA for NVA237 in 2014. ...