According to Novartis, the latest Phase 3 study of the QVA149 indacaterol/glycopyrronium DPI demonstrated a significant reduction in exacerbations of moderate-to-severe COPD compared to the Seebri Breezhaler glycopyrronium bromide DPI alone. The company says that it plans to submit regulatory filings in Europe and Japan by the end of 2012 and in the US at the end of 2014.
Novartis Head of Development Tim Wright commented, “We are looking forward to filing QVA149 initially in Europe and Japan, which will bring us another step closer to providing a full range of innovative COPD medicines to help physicians select the right treatment for the right patient at the right time.”
Shinichi Tamura, CEO of Sosei, which, with its partner Vectura, licensed glycopyrronium bromide to Novartis, said, “The SPARK study demonstrated a meaningful reduction in exacerbations in COPD patients, something that is of major benefit for patients and doctors and eases the burden of healthcare costs. We look forward to more detailed data from both glycopyrronium bromide (NVA237) and QVA149 at the upcoming European Respiratory Society meeting in Vienna in early September with the first filings for QVA149 expected in Europe and Japan by the end of this year.” Vectura Chief Executive Chris Blackwell echoed those sentiments.
Read the Novartis press release.
Read the Sosei press release.
Read the Vectura press release.
