Utibron Neohaler (indacaterol/glycopyrrolate), which is expected to be available in the first quarter of next year, can be used for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
It is not indicated for the treatment of asthma or sudden symptoms of COPD.
Novartis carried out a phase III Expedition trial program on 2,654 patients with COPD. It included two 12-week efficacy studies and one 52-week safety trial.
Utibron Neohaler demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components as well as placebo.
Improved lung function was also seen compared to placebo at five minutes following the initial dose and throughout the dosing interval. The company said it does not replace the use of a rescue inhaler.
The company said clinically meaningful enhancements were also demonstrated in health-related quality of life and reduced use of rescue medication compared to placebo.
Novartis Corporation and Novartis Pharmaceuticals Corporation US country head and president Christi Shaw said: "With this approval, the COPD community now has a new medicine that can help so many patients by improving not only their symptoms, but also their health-related quality of life."
The FDA has also approved Seebri Neohaler (glycopyrrolate) inhalation powder 15.6 mcg, a component of Utibron Neohaler, as a stand-alone monotherapy for the same COPD indication.
About 27 million people in the US are affected by COPD, which makes it hard to breathe.
Image: Novartis headquarters in Basel. Photo: courtesy of –Andrew- from Flickr.