Novartis set to file QVA149 filing in EU and Japan by end of year
Swiss drug major Novartis (NOVN: VX) announced yesterday that the fifth QVA149 (indacaterol maleate/glycopyrronium bromide) Phase III study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations compared to glycopyrronium bromide (Seebri Breezhaler). The product is partnered with UK-based inhalation product development company Vectura (LSE: VEC).
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.
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