Umeclidinium bromide regulatory update

GlaxoSmithKline submitted an NDA to FDA for umeclidinium bromide as monotherapy for long-term, once-daily maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). The pharma submitted an MAA to EMA for the long-acting muscarinic antagonist (LAMA) administered with the Ellipta inhaler last month (see BioCentury, April 29). ...