Novartis announced today that the US Food and Drug Administration (FDA) has approved the dual combination bronchodilator Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not indicated to treat asthma or sudden symptoms of COPD.
"Patients have told us about the tremendous impact their COPD can have on everyday activities," said Christi Shaw, US Country Head, President of Novartis Corporation and Novartis Pharmaceuticals Corporation. "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."
COPD is a progressive and life-threatening lung disease that makes it difficult to breathe. Nearly 27 million people in the US are affected by COPD, which ranks as the third leading cause of death in the US and is a major cause of serious long-term disability.
"As a treating physician, I want my patients with COPD to do as well as they can, but you'd be surprised how many I meet who seem to accept less than that," said Dr. Donald Mahler, Director of Respiratory Services, Valley Regional Hospital, Claremont, NH, who evaluated Utibron Neohaler in a phase III study. "I have seen first-hand how this dual bronchodilator provided meaningful symptom improvement to patients, a key objective in COPD management," added Dr. Mahler who is also Emeritus Professor of Medicine, Geisel School of Medicine at Dartmouth, NH.
Novartis expects that Utibron Neohaler will be available in the first quarter of 2016.
The FDA's decision is based on results of the phase III EXPEDITION trial program, which included 2,654 patients with COPD and consisted of two 12-week efficacy studies (FLIGHT 1 & 2) and one 52-week safety study (FLIGHT 3).
In the efficacy studies, Utibron Neohaler demonstrated superior and sustained improvements in lung function (FEV1 AUC0-12) at week 12, compared to its individual bronchodilator components (indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg) as well as placebo, all dosed twice-daily. Improvements in lung function were seen compared to placebo at 5 minutes after the first dose and sustained through the 12 hour dosing interval. Utibron Neohaler is not a rescue medication.
Utibron Neohaler also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo. Health status was assessed using the St. George's Respiratory Questionnaire (SGRQ) total score, which is a composite of symptoms, activities and impact on daily living.
Long-acting beta2-adrenergic agonists, such as indacaterol, one of the active ingredients in Utibron Neohaler, increase the risk of asthma-related death. Utibron Neohaler is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms. The most common adverse reactions seen in the efficacy studies (incidence greater than or equal to 1% and higher than placebo) were sore throat, runny nose, high blood pressure and back pain. Adverse reactions reported in the long-term safety trial were generally consistent with those observed in the 12-week studies.
The FDA also approved Seebri™ Neohaler® (glycopyrrolate) inhalation powder 15.6 mcg – which is one component of Utibron Neohaler – as a stand-alone monotherapy for the same COPD indication. Novartis expects that Seebri Neohaler will be available in the first quarter of 2016.
Utibron and Seebri are delivered via the low resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.
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