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Dual Bronchodilator Improves Lung Function in COPD Patients

Indacaterol/glycopyrronium meets all endpoints in late-stage trial

Positive results have been announced from the phase III development program for QVA149 (indacaterol/glycopyrronium, Novartis) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In the U.S., QVA149 and glycopyrronium (NVA237) are currently investigational.

The findings were presented at the American Thoracic Society (ATS) International Conference, held May 15–20 in Denver, Colorado.

The EXPEDITION trial program consists of two efficacy studies (FLIGHT 1 and 2) and one safety study (FLIGHT 3). The FLIGHT 1 and 2 trials met their primary endpoints, with QVA149 (indacaterol 27.5 mcg and glycopyrronium 12.5 mcg) demonstrating statistically significant and clinically meaningful improvements in lung function (i.e., the standard area under the curve from 0 to 12 hours [AUC0–12]) for the forced expiratory volume at 1 second [FEV1]) at week 12 compared with its individual components and placebo, all dosed twice-daily.

In these studies, QVA149 also demonstrated improvements for all secondary endpoints at week 12. This included the key secondary endpoint of health status, as well as trough FEV1, peak FEV1, dyspnea, and reduced use of rescue medication compared with the individual components and placebo.

A pooled analysis of the FLIGHT 1 and 2 trials found that QVA149 had similar safety outcomes at 12 weeks compared with its mono-components indacaterol 27.5 mcg and glycopyrronium 12.5 mcg, as well as with placebo. In the FLIGHT 3 study, the incidence rates of adverse events and serious adverse events for QVA149 27.5/12.5 mcg and QVA149 27.5/25 mcg, each given twice daily, were similar to those of once-daily indacaterol 75 mcg over a 52-week treatment period.

In FLIGHT 1, QVA149 improved the FEV1 AUC0–12h at week 12 compared with indacaterol (least square mean [LSM] treatment difference: 94 mL; P < 0.001), glycopyrronium (98 mL; P < 0.001), and placebo (231 mL; P < 0.001). QVA149 also demonstrated statistically significant improvement in trough FEV1 compared with its individual components and placebo after 12 weeks of treatment (LSM treatment differences: 81 mL, 110 mL, and 213 mL, respectively; all P < 0.001) and peak FEV1 (LSM treatment difference: 109 mL, 100 mL, and 260 mL, respectively; all P <0.001).

In FLIGHT 2, QVA149 demonstrated superior bronchodilation compared with indacaterol, glycopyrronium, and placebo. Improvements in the FEV1 AUC0-12h at week 12 (LSM treatment differences) were 112 mL, 79 mL, and 262 mL, respectively (all P < 0.001). QVA149 also showed a statistically significant improvement in trough FEV1 compared with indacaterol, glycopyrronium, and placebo after 12 weeks of treatment (LSM treatment differences: 78 mL, 87 mL, and 233 mL, respectively; all P < 0.001) and in peak FEV1 (LSM treatment differences: 139 mL, 86 mL, and 290 mL, respectively; all P < 0.001).

QVA149 (indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg) and one of its components, NVA237 (glycopyrrolate 15.6 mcg), are currently under review by the FDA as twice-daily therapies for long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. QVA149 and NVA237 are administered via the Neohaler device. The indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg dose strength is equivalent to indacaterol 27.5 mcg/glycopyrronium 12.5 mcg.

Source: PR Newswire; May 20, 2015.

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