Novartis presents data of two US COPD Phase III programmes

20th May 2015 (Last Updated May 20th, 2015 18:30)

Swiss drugmaker Novartis has presented positive results from two pivotal Phase III clinical trial programmes for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Novartis

Swiss drugmaker Novartis has presented positive results from two pivotal Phase III clinical trial programmes for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

According to the company, the Expedition, including Flight I, II and III studies and Gem programmes reached their primary and secondary endpoints.

Expedition data showed that QVA149 when administered twice-daily, improved lung function (FEV1 AUC0-12h) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, met the primary objective.

Novartis Pharmaceuticals development global head Vasant Narasimhan said: "These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life."

In the Gem I and II, NVA237 when administered twice-daily showed better improvements in lung function (FEV1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo.

The Expedition programme, including Flight I and II, are 12-week multicentre, randomised, double-blind, parallel-group, placebo and active-controlled studies designed to evaluate the efficacy, safety and tolerability of QVA149 in moderate-to-severe COPD patients.

Flight III was a 52-week randomised, double-blind and parallel-group study designed to assess the safety and tolerability of QVA149 27.5/12.5 mcg, administered twice-daily, compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients.

Gem I and II were 12-week multi-centre, randomised, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of NVA237 12.5mcg, administered twice-daily, in moderate-to-severe COPD patients.

Outside of the US, QVA149 is marketed as Ultibro Breezhaler 110/50mcg and NVA237 is marketed as Seebri Breezhaler 50mcg.


Image: Chest X-ray demonstrating severe COPD. Photo: courtesy of James Heilman, MD.