Indacaterol/glycopyrronium bromide: Phase III data
Top-line data from the double-blind, international Phase III SPARK trial in 2,224 patients with severe to very severe COPD showed that once-daily QVA149 met the primary endpoint of reducing the rate of moderate to severe COPD exacerbations from baseline to week 64 vs. once-daily 50 µg NVA237 (p=0.038). QVA149 missed the secondary endpoint of reducing the rate of moderate to severe COPD exacerbations vs. open-label 18 µg tiotropium (p=0.096), but did significantly reduce the overall rate of all exacerbations vs. both NVA237 (p=0.001) and tiotropium (p=0.002). The adverse event profile of QVA149 was similar to that of both NVA237 and tiotropium.
The Phase III IGNITE program of QVA149 consists of 10 trials, including the SPARK trial. In April, the partners reported top-line data from the Phase III BRIGHT, SHINE, ENLIGHTEN and ILLUMINATE trials (see BioCentury, April 9 & April 30). Novartis expects to complete the Phase III BLAZE, ARISE and BEACON trials by year end. The pharma plans to submit regulatory applications for QVA149 in Europe and Japan in 4Q12, while a U.S. submission is slated for year end 2014. NVA237 is under review in Europe and Japan, where it is known as Seebri Breezhaler, while Novartis plans to submit an NDA to FDA for NVA237 in 2014. ...