Novartis is to file its combination chronic obstructive pulmonary disease drug QVA149 in Europe and Japan after presenting more positive late-stage data.
The Swiss major says that the fifth Phase III study of QVA149, a combination of Novartis' own Onbrez Breezhaler (indacaterol), a long-acting beta 2-agonist (LABA) and NVA237 (glycopyrronium), a long-acting muscarinic antagonist (LAMA), met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium (also known as Seebri Breezhaler) alone. As a result the firm intends to file QVA149 in Europe and Japan in the fourth quarter, while a US submission is expected at the end of 2014.
To date, the first five studies of the combo, which is partnered with the UK's Vectura and Japan's Sosei, have all met their primary endpoints of efficacy, safety, exercise endurance, and reduction of exacerbations, Novartis says. The Basel-based group added that a further analysis of the data demonstrated that QVA149 was statistically significantly more effective in reducing the overall rate of all exacerbations (mild, moderate and severe) compared to glycopyrronium and Boehringer Ingelheim/Pfizer's blockbuster Spiriva (tiotropium).
If approved, QVA149 will compete with the latter and GlaxoSmithKline's Seretide/Advair (salmeterol/fluticasone).