Novartis Submits NDAs for Investigational COPD Drugs Following Promising Trials

January 12, 2015

Ryan Marotta, Assistant Editor

Article

Novartis announced that it has submitted New Drug Applications to the FDA for QVA149 and NVA237, investigational drugs for the long-term maintenance treatment of chronic obstructive pulmonary disease, following positive results from phase 3 trials of the drugs.

Novartis announced that it has submitted New Drug Applications (NDAs) to the FDA for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide), investigational drugs for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), following positive results from phase 3 trials of the drugs.

The efficacy, safety, and tolerability of twice-daily QVA149 27.5/12.5 mcg was assessed in Novartis’ EXPEDITION program, which included 2 identical 12-week, multicenter, randomized, double-blind, parallel-group, placebo and active controlled studies. Compared with its monotherapy components, indacaterol and glycopyrronium bromide, QVA149 demonstrated statistically significant and clinically meaningful improvements in lung function in patients with moderate to severe COPD at Week 12. The study also found that QVA149 led to improvements in overall health status and rescue medication usage compared with placebo at Week 12.

The efficacy and safety of twice-daily NVA237 12.5 mcg were assessed in Novartis’ GEM studies, which included several 12-week multicenter, randomized, double-blind, placebo controlled trials. Compared with placebo, NVA237 demonstrated significant and clinically meaningful improvements in lung function, as well as improved overall health, in patients with moderate to severe COPD at Week 12.

“These data once again confirm the strong efficacy and favourable safety profiles of both QVA149 and NVA237,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals, in a press release. “With submissions to the US FDA now complete for both treatments, we are closer to offering US patients with COPD a broader range of treatment options to help improve the significant burden of reduced lung function, and to help improve their lives.”

The common adverse events reported for both drugs were comparable to placebo and, in the case of QVA149, the individual components, across their respective studies.