CHMP backs Relvar Ellipta for asthma and COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) said EMA's CHMP issued a positive opinion recommending approval of an MAA for Relvar Ellipta fluticasone furoate/vilanterol to treat asthma and chronic obstructive pulmonary disease (COPD). The product -- a once-daily, fixed dose combination of the inhaled corticosteroid fluticasone furoate and a long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol administered with the dry powder Ellipta inhaler -- is approved in the U.S. and Canada as Breo Ellipta to treat airflow obstruction in patients with COPD and to reduce COPD exacerbations in patients with a history of exacerbations. The partners expect a final decision from the European Commission on the MAA next quarter. On Thursday, Theravance was up $0.38 to $41.20. ...