General Information

Utibron Neohaler is a fixed dose combination of glycopyrronium bromide, a once-daily long-acting muscarinic antagonist, and indacaterol, a once-daily long-acting beta-2 agonist.

Utibron Neohaler is specifically indicated for the long term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Utibron Neohaler is supplied as an inhalation powder, for oral inhalation use. The recommended dose is the inhalation of the contents of one Utibron capsule twice daily using the Neohaler device. Utibron Neohaler should be administered at the same time of the day, (1 capsule in the morning and 1 capsule in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 capsule twicedaily) is not recommended

Clinical Results

FDA Approval

The FDA approval of Utibron Neohaler was 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 also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo.

Side Effects

Adverse effects associated with the use of Utibron Neohaler may include, but are not limited to, the following:

• nasopharyngitis
• hypertension

Utibron Neohaler comes with a black box warning of the potential for long-acting beta2-adrenergic agonists (LABAs) to increase the risk of asthma-related death.

Mechanism of Action

Utibron Neohaler is a fixed dose combination of glycopyrronium bromide, a once-daily long-acting muscarinic antagonist, and indacaterol, a once-daily long-acting beta-2 agonist.

Additional Information

For additional information regarding Utibron Neohaler or the long term, maintenance treatment of airflow obstruction in patients with COPD, please visit http://www.pharma.us.novartis.com/product/pi/pdf/utibron.pdf