According to Sosei, Novartis and the FDA have agreed on Phase 3 trial design for QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide, which should put the company on track to file an application for NVA237 early in 2014 and an application for QVA149 by the end of that year. Novartis licensed NVA 237 from Sosei and Vectura.
Both Sosei and Novartis also confirmed that a fourth Phase 3 study of QVA149 has met its primary endpoint, demonstrating superiority in lung function of a once-daily dose compared to twice daily doses of Advair (Seretide) fluticasone/salmeterol in patients with moderate to severe COPD.
Sosei CEO Shinichi Tamura said, “The ILLLUMINATE study will be an important part of the regulatory submission for QVA149 and achieving superior lung function given once daily versus twice-daily Seretide gives us more confidence in the potential of QVA149 in the treatment of patients with COPD. We now have clarity on US filing timelines for both NVA237 and QVA149 and we look forward to a decision from the EU regulators on NVA237 in the near future”
Novartis filed an MAA for an NVA237 dry powder inhaler to be marketed as the Seebri Breezhaler in September 2011.
Read the Sosei press release.
