The SHINE, BRIGHT and ENLIGHTEN studies, part of IGNITE Phase III trial program intended to form the basis for an NDA filing in COPD, met their primary endpoints.
The SHINE has met the primary endpoint by demonstrating the superiority in trough FEV (p<0.001) of once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD.
The BRIGHT showed that patients experienced significantly better exercise endurance versus placebo (p=0.006).
ENLIGHTEN demonstrated that QVA149 was well tolerated with a safety and tolerability profile similar to placebo, the company said.
QVA149, a bronchodilator with dual mode of action, is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist indacaterol, and the long-acting muscarinic antagonist glycopyrronium bromide.
Novartis Pharmaceuticals development head Tim Wright said: "Meeting the primary endpoints in the IGNITE Phase III clinical trial program signals significant progress in establishing the potential of QVA149, which is expected to be the third innovative medicine in our strong COPD portfolio."