Anoro Ellipta umeclidinium bromide/vilanterol regulatory update

In December, Theravance and GlaxoSmithKline said Canada approved Anoro Ellipta umeclidinium bromide/vilanterol for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The product 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).

FDA approved Anoro Ellipta for the indication in December (see BioCentury, Dec. 23, 2013). Theravance said a U.S. launch is slated for this quarter. GSK and Theravance are partnered under a 2002 deal to develop compounds to treat asthma and COPD (see BioCentury, Jan. 13, 2003). ...