TOKYO announced today that
- SPARK demonstrated QVA149 statistically significantly reduced rate of moderate-to-severe exacerbations compared to glycopyrronium 50 mcg.
- Study showed QVA149 statistically significantly reduced overall exacerbation rates compared to glycopyrronium 50 mcg and open-label tiotropium 18 mcg
- SPARK is the final study of the IGNITE Phase III clinical trial program intended for initial regulatory filings
Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the information released today by Novartis that results from the fifth QVA149 (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 (Seebri Breezhaler)
. SPARK is the final study intended for initial regulatory filings of QVA149 in Europe and Japan, which are expected in Q4 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
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SPARK met its primary endpoint by demonstrating that patients treated with once-daily (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)[1]. 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 18 mcg.
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 50 mcg (p=0.001) and OL tiotropium 18 mcg (p=0.002). The adverse event (AE) profile of QVA149 was similar to both glycopyrronium 50 mcg and OL tiotropium 18 mcg.
The management of COPD exacerbations is important to both patients and physicians, as exacerbations can impose a significant burden of morbidity, mortality, reduced quality of life and healthcare costs. Frequent exacerbations are linked to an accelerated decline in lung function and patients are also known to have a poorer quality of life. Admissions to hospital due to exacerbations are increasing and patients with more severe underlying disease account for around 70% of the direct medical costs of COPD.
PR Newswire