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COPD Drug Meets Primary Endpoint in Phase III Trial

U.S. filing expected in 2014 (Aug. 30)

Novartis announced on August 30 that SPARK, the fifth phase III study of QVA149 (indacaterol maleate and glycopyrronium bromide), met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared with 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.

SPARK met its primary endpoint by demonstrating that patients treated with once-daily (QD) investigational QVA149 for 64 weeks demonstrated a significantly lower rate of moderate-to-severe COPD exacerbations compared with 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 receiving QVA149 compared with open-label tiotropium 18 mcg.

A further analysis of the data demonstrated that QVA149 was significantly more effective in reducing the overall rate of all exacerbations (mild, moderate, and severe) compared with QD glycopyrronium 50 mcg (P = 0.001) and open-label tiotropium 18 mcg (P = 0.002). The adverse-event profile of QVA149 was similar to that of both comparators.

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. Patients with more severe underlying disease account for approximately 70% of the direct medical costs of COPD.

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of the long-acting beta2-adrenergic agonist (LABA) indacaterol maleate and the investigational long-acting muscarinic antagonist (LAMA) glycopyrronium bromide.

For more information, visit the Novartis Web site.

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