Arcapta Neohaler regulatory update

FDA approved an NDA from Novartis for 75 µg once-daily Arcapta Neohaler indacaterol for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The label for the inhaled long-acting adrenergic receptor beta 2 ( ADRB2) agonist (LABA) contains a boxed warning about an increased risk of asthma-related death. All LABAs should not be used in patients with asthma, unless used with a long-term asthma control medication. In March, an FDA advisory committee voted 13-4 in favor of approving the 75 µg dose of Arcapta, but voted 12-5 against approving the 150 µg dose. The panel questioned whether the high dose was necessary given the risk of severe asthma exacerbations and asthma-related deaths associated with LABAs (see BioCentury, March 14). ...