Novartis has received approval from the US Food and Drug Administration (FDA) for its new dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder for patients with chronic obstructive pulmonary disease (COPD).
Expected to be available in the first quarter of next year, Utibron Neohaler can be used for the long-term maintenance treatment of airflow obstruction in COPD patients, including chronic bronchitis and/or emphysema.
Utibron Neohaler is not indicated for treatment of asthma or sudden symptoms of COPD.
The approval is based on data from the Phase III Expedition trial programme, which included 2,654 COPD patients.
"The COPD community now has a new medicine that can help so many patients."The programme included two 12-week efficacy studies (FLIGHT 1 & 2) and one 52-week safety study (FLIGHT 3).
In FLIGHT 1 & 2 studies, Utibron Neohaler showed superior and sustained improvements in lung function (FEV1 AUC0-12) at week 12, compared with its individual bronchodilator components, as well as placebo, all dosed twice-daily.
In these trials, improvements in lung function were observed compared to placebo at five minutes after the first dose and sustained through the 12 hour dosing interval.
Novartis Pharmaceuticals US Country head and president Christi Shaw said: "Patients have told us about the tremendous impact their COPD can have on everyday activities.
"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. This means the possibility of doing things that matter to them."
The company noted that Utibron Neohaler showed clinically meaningful enhancements in health-related quality of life and reduced use of rescue medication compared to placebo.
The FDA has also approved Seebri Neohaler (glycopyrrolate) inhalation powder 15.6mcg, a component of Utibron Neohaler, as a stand-alone monotherapy for the same COPD indication.
Both Utibron and Seebri are delivered via the low-resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.
