FDA approves Utibron Neohaler (indacaterol/glycopyrrolate) for chronic obstructive pulmonary disease- Novartis

The FDA has approved the dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder, from Novartis, 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.

The FDA's decision is based on results of the phase III EXPEDITION trial programme, 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 µg and glycopyrrolate 15.6 µg) 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.

Comment: Utibron Neohaler offers patients a substantial advantage with its once-daily dosing formulation. The once-daily formulation will encourage patients currently taking single-formulation LAMAs and LABAs to switch to this new formulation as they seek to simplify their treatment regimens, which is expected to improve compliance and therefore improve outcomes to therapy. Furthermore, the demonstration of superior efficacy to twice daily Advair (salmeterol plus fluticasone) will also encourage patient share to shift from popular ICS/LABA inhalers to Utibron Neohaler (Ultibro Breezhaler in EU, where the combination was approved in 2014).