Novartis files NDA at FDA for Seebri Breezhaler (NVA 237)for COPD

Novartis has filed a new drug application (NDA) at the FDA for once a day Seebri Breezhaler (NVA 237) (glycopyrronium bromide), a novel inhaled LAMA, for treatment of Chronic Obstructive Pulmonary Disease (COPD). This application is supported by evidence from the GEM 1 and 2 studies, where NVA 237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo thus meeting its primary objective.

Comment: Seebri Breezhaler, if approved, will compete with Spiriva from Boehringer Ingelheim whose patent expires in 2018 and Striverdi Respimat (olodaterol)- FDA and EU recently approved as well as forthcoming Spiriva Respimat Soft Mist Inhaler (olodaterol + tiotropium). QVA 149 from Novartis is the combination of Onbreezhaler/Arcapta Neohaler (indacaterol) and Seebri Breezhaler (glycopyrronium bromide).

Seebri Breezhaler was EU approved in 2012.