Bevespi Aerosphere glycopyrrolate/formoterol fumarate regulatory update

FDA approved an NDA for twice-daily Bevespi Aerosphere glycopyrrolate/formoterol fumarate from AstraZeneca for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere delivers glycopyrrolate ( PT001), a long-acting muscarinic antagonist (LAMA), and formoterol fumarate (PT005), a long-acting adrenergic receptor beta 2 ( ADRB2) agonist (LABA), via a hydrofluoroalkane metered-dose inhaler. AZ plans to launch the product in 1Q17 but has not yet set a price. ...