NVA 237 meets endpoints in GEM studies for treatment of COPD- Novartis

Novartis announced positive top-line results from the pivotal Phase III clinical trial program for NVA 237 (glycopyrronium bromide) to support a New Drug Application (NDA) with the FDA for the long-term maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). The results from the GEM clinical trial programs met their primary and secondary endpoints.

In the GEM 1 and 2 studies, twice-daily 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; meeting its primary objective. An improvement in health status was also observed in patients at Week 12.The adverse events reported for NVA 237 were comparable to placebo across the GEM studies.Data from the GEM programs are expected to be presented at major medical congresses later this year.

Comment: NVA 237 was approved in the EU as Seebri Breezhaler in 2012.