Phase 3 Study Update of NVA237 for COPD
Sosei Group Corporation announced results reported by Novartis from its Phase 3 GLOW2 study of NVA237 (glycopyrronium bromide) for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD). GLOW2 was a 52-week, double-blind, placebo-controlled, parallel-group study involving 1,066 patients to assess the efficacy, safety, and tolerability of NVA237. Patients were randomized into three treatment arms receiving either once-daily NVA237 50mcg, placebo, or once-daily open-label tiotropium (Spiriva HandiHaler; Boehringer Ingelheim Pharma) 18mcg. Study results showed that patients taking NVA237 50mcg once daily significantly improved lung function relative to placebo (P<0.001), with similar efficacy to open-label tiotropium. Further efficacy and safety results from GLOW2 will be presented at a scientific congress in 2012, and the data will be used to support an application for regulatory approval to be filed before the end of 2011.
NVA237 is a once-daily, long-acting muscarinic antagonist (LAMA) being developed to treat COPD.
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