A first look at data from pivotal Phase III trials assessing Novartis’ chronic obstructive pulmonary disorder medicines QVA149 and NVA237 show improvements across lung function and quality of life measures.
Data from the EXPEDITION program showed that twice-daily QVA149 (indacaterol/glycopyrronium bromide; marketed as Ultibro Breezhaler outside of the US) boosted lung function (as measured by FEV1) versus placebo and its individual components after 12 weeks’ treatment.
The dual bronchodilator was also shown to improve breathlessness, overall quality of life and COPD rescue medication use, as well as significant improvements in FEV1 at 5 min and 15 min compared to placebo, the Swiss drugs giant said.
In the GEM 1 and 2 studies, twice-daily NVA237 (glycopyrronium bromide; marketed as Seebri Breezhaler outside the US) also demonstrated significant and clinically meaningful improvements in lung function at week 12 compared to placebo, while a benefit across COPD symptoms, quality of life and rescue medication use was also recorded.
Novartis is hoping that its medicines will help address the urgent need for new COPD treatments in the US, given that many of the 27 million patients with the condition remain symptomatic despite receiving medical care.
Evidence from the EXPEDITION and GEM programs has been used to support current QVA149 and NVA237 US regulatory submissions, it noted.
Ultibro Breezhaler is currently approved for use in over 60 countries, while Seebri Breezhaler is already on the market in over 80 countries.