Glycopyrronium bromide: Phase III data

The double-blind, international Phase III GLOW2 trial in 1,066 patients with moderate to severe COPD showed that once-daily 50 µg inhaled NVA237 met the primary endpoint of significantly improving trough FEV1 at 24 hours post-dose at week 12 vs. placebo (p<0.001). NVA237 also met the secondary endpoints of significantly improving breathlessness as measured by TDI scores at week 26, quality of life as measured by SGRQ scores at week 52, time to first COPD exacerbation and daily rescue medication use vs. placebo. Additionally, NVA237 led to similar improvements in lung function compared to open-label, once-daily 18 µg Spiriva HandiHaler tiotropium. Details about the Spiriva results were not disclosed. NVA237 was well tolerated with a similar incidence of adverse events between treatment groups.

Novartis plans to submit regulatory applications in the U.S. and EU for NVA237 as a once-daily monotherapy for COPD, with the pharma's first submission expected by year end. Novartis previously reported data from the Phase III GLOW1 trial in the indication showing that NVA237 met the primary endpoint of significantly improving trough FEV1 from baseline to week 12 vs. placebo (see BioCentury, April 25). Novartis is also developing QVA149, a fixed-dose combination of NVA237 and indacaterol, an adrenergic receptor beta 2 (ADRB2) agonist, for the indication. Regulatory applications for QVA149 are expected to be submitted in 2012. ...