Novartis COPD Dual Combination Bronchodilator Approved

Novartis’ dual combination bronchodilator Utibron Neohaler inhalation powder for patients with chronic obstructive pulmonary disease (COPD) has received FDA approval.

The FDA decision was based on results from a trial of 2654 patients with COPD. The phase III EXPEDITION trial consisted of two 12-week efficacy studies and a 52-week safety study. The efficacy studies found Novartis’ treatment was superior in demonstrating sustained lung function improvements compared to the individual components of the bronchodilator.

Just 5 minutes after the first dose the dual combination treatment showed improvements in lung function that were sustained through the 12-hour dosing interval.

"Patients have told us about the tremendous impact their COPD can have on everyday activities," Christi Shaw, US country head, president of Novartis Corporation and Novartis Pharmaceuticals Corporation, said in a statement. "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."

Utibron Neohaler showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication. The therapy is not indicated to treat asthma or sudden symptoms of COPD.

The most common adverse reactions (higher than placebo) were sore throat, runny nose, high blood pressure, and back pain.

"I have seen first-hand how this dual bronchodilator provided meaningful symptom improvement to patients, a key objective in COPD management,” said Donald Mahler, MD, director of Respiratory Services, Valley Regional Hospital, Claremont, NH, who evaluated Utibron Neohaler in a phase III study.