Tovanor Breezhaler: Additional Phase III data

Pooled data from 1,888 patients enrolled in the double-blind, international Phase III GLOW1 and GLOW2 trials showed that 50 µg once-daily NVA237 significantly increased trough FEV1 by 98 mL at day 1, 103 mL at 12 weeks, 125 mL at 26 weeks and 108 mL at 52 weeks vs. placebo (p<0.001 for all). NVA237 also significantly increased trough FVC by 187 mL at day 1, 190 mL at 12 weeks, 205 mL at 26 weeks and 179 mL at 52 weeks vs. placebo (p<0.001 for all). Additionally, NVA237 significantly increased FEV1 AUC from 0-4 hours, 0-12 hours, 0-24 hours and 12-24 hours vs. placebo on day 1 and weeks 12, 26 and 52 (p<0.05 for all). NVA237 also non-significantly improved trough FEV1, FEV1 AUC and FVC at all time points vs. once-daily 18 µg Spiriva tiotropium.

In a separate analysis of pooled data from 1,854 patients enrolled in the GLOW1 and GLOW2 trials, NVA237 significantly prolonged time to first moderate to severe exacerbation at week 26 (p<0.001) and at week 52 (p<0.001) vs. placebo (p<0.001). Spiriva also significantly delayed time to first moderate to severe exacerbation at week 26 (p=0.026) and at week 52 (p<0.001). NVA237 also significantly reduced the rate of moderate or severe exacerbations at weeks 26 and 52 vs. placebo (p<0.005 for both), while Spiriva was not significantly different from placebo at either time point (p=0.085 and p=0.179). NVA237 and Spiriva both led to significant improvements at weeks 26 and 52 vs. placebo in TDI total score (p<0.05 for all) and in mean SGRQ score (p<0.001 for NVA237, p<0.05 for Spiriva). Data were presented at the European Respiratory Society meeting in Vienna. ...