FDA approves Anoro Ellipta for COPD
FDA approved an NDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Anoro Ellipta umeclidinium bromide/vilanterol for long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). GSK said it is the first once-daily product approved in the U.S. that combines two long-acting bronchodilators for COPD. Anoro Ellipta is a fixed-dose inhaled dry powder formulation of umeclidinium bromide, a long-acting muscarinic antagonist (LAMA), and vilanterol, a long-acting adrenergic receptor beta 2 agonist (LABA).
The approval triggered a $30 million milestone payment to GSK from partner Theravance Inc. (NASDAQ:THRX) under a 2002 deal to develop compounds to treat asthma and COPD. GSK is eligible for a second $30 million milestone following the drug's U.S. launch, which GSK anticipates next quarter. ...