GSK, Theravance report asthma data for Breo Ellipta

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Theravance Inc. (NASDAQ:THRX) said once-daily fluticasone furoate/vilanterol administered with the dry powder Ellipta inhaler met the primary endpoint in a 990-patient Phase III trial to treat moderate to severe persistent asthma. In the trial, 100/25 ug fluticasone furoate/vilanterol improved 0-24 hour weighted mean serial forced expiratory volume in 1 second (FEV1), the primary endpoint, by 108 mL at the end of the 12-week treatment period vs. once-daily 100 ug fluticasone furoate (p<0.001). The pharma said the data "will inform" its discussions with FDA on the "regulatory requirements of an asthma indication" in the U.S. The product -- a once-daily, fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol -- is already approved in the U.S. and Canada as Breo Ellipta to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations in patients with a history of exacerbations.

Last month, the European Commission approved the product as Relvar Ellipta to treat asthma not adequately controlled with "as needed" treatment alone in patients 12 years of age and older and for COPD in adults with a history of exacerbations despite regular bronchodilator therapy. The product is also approved in Japan to treat bronchial asthma in patients who require combination therapy with inhaled corticosteroids plus inhaled LABAs. Theravance and GSK partnered to develop compounds to treat asthma and COPD in 2002 (see BioCentury Extra, Nov. 18). ...