Novartis announced that the Food and Drug Administration (FDA) has approved Utibron Neohaler (indacaterol and glycopyrrolate) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The FDA has also approved Seebri Neohaler (glycopyrrolate) inhalation powder as a stand-alone monotherapy for the same COPD indication.
The FDA approval was based on data from the Phase 3 EXPEDITION trial program (n=2,654) that enrolled patients with COPD and consisted of two 12-week efficacy studies (FLIGHT 1 & 2), and one 52-week safety study (FLIGHT 3). Utibron Neohaler showed superiority and sustained improvements in lung function at Week 12 vs. its individual bronchodilator components (indacaterol 27.5mcg and glycopyrrolate 15.6mcg) and placebo, all dosed twice daily. Also, Utibron Neohaler demonstrated improvements in lung function vs. placebo at 5 minutes after the first dose and sustained through the 12-hour dosing interval.
Utibron Neohaler combines indacaterol, a long-acting beta2-adrenergic agonist (LABA), and glycopyrrolate, a long-acting muscarinic antagonist (LAMA).
Utibron Neohaler will be available as 27.5mcg/15.6mcg strength inhalation powder in capsules in 6- and 60-count blister packs. Seebri Neohaler will be available as 15.6mcg inhalation powder in capsules in 60-count blister packs. Both inhalers are expected to launch in the first quarter of 2016.
For more information call (888) 669-6682 or visit Novartis.com.