Positive Phase III results for QVA 149 ( indacaterol/glycopyrronium bromide) to support NDA for FDA for COPD- Novartis

Novartis announced positive top-line results from the pivotal Phase III clinical trial programs for QVA 149 (indacaterol/glycopyrronium bromide) to support a New Drug Application (NDA ) with the FDA for the long-term maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) programs met their primary and secondary endpoints.

The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA 149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients. Improvements in overall health status, a secondary endpoint based on the St George's Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA 149 compared to placebo at Week 12.The common adverse events reported for QVA 149 were comparable to the individual components and placebo across the EXPEDITION studies.

The EXPEDITION Program consisted of studies, including FLIGHT 1 and 2, which were identical 12-week, multi-center, randomized, double blind, parallel-group, placebo and active controlled studies to assess the efficacy, safety, and tolerability of QVA 149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare twice-daily QVA 149 27.5/12.5 mcg to its monotherapy components in terms of lung function (FEV1 AUC0-12h) at Week 12. FLIGHT 3 was a 52-week randomized double blind, parallel-group study to assess the safety and tolerability of twice-daily QVA 149 27.5/12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study.

QVA 149 was EU approved for COPD as Ultibro Breezhaler in September 2014.

Comment: QVA 149 is known as Ultibro Breezhaler in the EU and is not yet approved in the US. Indacaterol monotherapy is known as the Onbreezhaler in the EU and Arcapta in the US and approved in both. NVA 237 (glycopyrronium bromide) monotherapy is known as SeebriBreezhaler in the EU and is not yet approved in the US. QVA 149 is seen to be at a disadvantage due to the need to reload its Breezhaler after each use compared to the GSK drugs, Anoro Ellipta and Breo Ellipta that have a multi-dose Ellipta inhaler.