The pivotal Phase III GLOW2 clinical trial showed that once-daily NVA237 (glycopyrronium bromide) 50 mcg significantly improved lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) relative to placebo (p<0.001), with similar efficacy to open-label tiotropium.
“NVA237 has demonstrated its potential benefit for COPD patients in two large pivotal Phase III studies,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharmaceuticals. “This new study adds to the growing evidence that NVA237 could be an important treatment option for COPD, and supports our plans to develop a fixed-dose combination with our long-acting beta2-agonist Onbrez® Breezhaler® (indacaterol).”
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 in patients with COPD. Patients were randomised into three treatment arms receiving either once-daily NVA237 50 mcg or placebo (double-blind), or once-daily tiotropium 18 mcg (open label). They were also permitted to use COPD background therapy and rescue medication.
Further data from GLOW1 will be presented at the European Respiratory Society congress in Amsterdam in September 2011. 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 was licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.