Novartis and Sosei Group, an international biopharmaceutical company based in Japan, released results from the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) phase III study, SPARK, which met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide (Seebri Breezhaler).
SPARK is the final study intended for initial regulatory filings of QVA149 in Europe and Japan, which are expected in the fourth quarter of 2012. U.S. filing of QVA149 is expected at the end of 2014. To date, the first five studies of the IGNITE QVA149 phase III clinical trials program have all met their primary endpoints of efficacy, safety, exercise endurance and reduction of exacerbations.
SPARK was a 64-week, multi-center, randomized, double-blind, parallel-group, active controlled study that enrolled 2, 224 patients with severe to very severe COPD. Patients received QVA149 (indacaterol maleate 110µg / glycopyrronium 50µg) versus glycopyrronium 50µg and OL tiotropium 18µg once-daily (QD). QVA149 is an investigational inhaled, once-daily, fixed-dose combination of the long-acting beta2-adrenergicagonist (LABA) indacaterol maleate and the investigational long-acting muscarinic antagonist (LAMA) glycopyrronium bromide.
SPARK met its primary endpoint by demonstrating that patients treated with QVA149 demonstrated a clinically meaningful and statistically significant lower rate of moderate-to-severe COPD exacerbations compared to patients treated with glycopyrronium 50µg (p=0.038). The study also showed that the rate of moderate-to-severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to open-label (OL) tiotropium 18µg.
A further analysis of the data demonstrated that QVA149 was statistically significantly more effective in reducing the overall rate of all exacerbations (mild, moderate and severe) compared to glycopyrronium 50µg (p=0.001) and OL tiotropium 18µg (p=0.002). The adverse event profile of QVA149 was similar to both glycopyrronium 50µg and OL tiotropium 18µg.
Shinichi Tamura, CEO of Sosei, said, "We look forward to more detailed data from both glycopyrronium bromide (NVA237) and QVA149 at the upcoming European Respiratory Society meeting in Vienna in early September with the first filings for QVA149 expected in Europe and Japan by the end of this year."