Novartis' QVA149 meets in Phase III BLAZE trial

Novartis AG (NYSE:NVS; SIX:NOVN) said once-daily QVA149 met the primary endpoint of improving patient self-reported shortness of breath during daily activities as measured by Transition Dyspnea Index (TDI) scores from baseline to week six vs. placebo (p<0.001) in the Phase III BLAZE trial to treat chronic obstructive pulmonary disease (COPD). Data were presented at the American Thoracic Society meeting in Philadelphia. QVA149 is a fixed-dose combination of glycopyrronium bromide, an inhaled long-acting muscarinic receptor antagonist (LAMA), and indacaterol, a long-acting adrenergic receptor beta 2 agonist (LABA). The BLAZE trial, which enrolled 247 patients with moderate to severe COPD, is part of the 10-trial Phase III IGNITE program of QVA149. Including BLAZE, QVA149 has met the primary endpoint in six of the trials. The ARISE, BEACON, RADIATE and LANTERN trials have not yet reported data.

Last year, Novartis submitted regulatory applications for QVA149 for COPD in Europe and Japan. Data from the BLAZE trial were not included in the submissions. Novartis plans to submit a regulatory application for QVA149 to FDA by the end of 2014. ...