Three Phase 3 studies of Novartis’s QVA149 indacaterol /glycopyrronium bromide dry powder inhaler for the treatment of COPD have met their primary endpoints according to the company. The SHINE study demonstrated superiority in trough FEV1 for QVA 149 compared to indacaterol alone, glycopyrronium alone, tiotropium, and placebo in more than 2,000 patients with moderate to severe COPD. The BRIGHT study showed significant improvements in exercise endurance vs. placebo, and the ENLIGHTEN study showed a similar safety and tolerability profile for QVA 149 compared to placebo.
Novartis Head of Development Tim Wright commented, “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. Novartis is committed to addressing the unmet needs of COPD patients and improving their quality of life by providing innovative medicines and devices.”
The company says that it expects to complete 7 of 10 of the studies included in the IGNITE program by the end of 2012. Earlier this month, Novartis launched the Arcapta Neohaler 75 mcg indacaterol DPI in the US.
Read the Novartis press release.
