Novartis (NVS) announced that the fifth QVA149,or indacaterol maleate / glycopyrronium bromide, Phase III study, Spark, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide or 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.
US 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, the company said.
The company noted that SPARK met its primary endpoint by demonstrating that patients treated with once-daily or QD investigational QVA149 for 64 weeks demonstrated a clinically meaningful and statistically significant lower rate of moderate-to-severe COPD exacerbations compared to patients treated with QD glycopyrronium 50 mcg (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 or OL tiotropium 18 mcg.
The company added that the first five studies, or Illuminate, Shine, Bright, Enlighten, Spark, have already completed in 2012 with three additional studies, or Blaze, Arise, Beacon, expected to complete by the end of the year.
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