FDA postpones Breo advisory committee

FDA postponed this Thursday's meeting of the agency's Pulmonary-Allergy Drugs Advisory Committee, which was set to discuss an NDA from Theravance Inc. (NASDAQ:THRX) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Breo fluticasone furoate/vilanterol to treat chronic obstructive pulmonary disease (COPD). A GSK spokesperson said the meeting was postponed due to adverse weather and that the agency has not set a new date for the meeting. FDA announced the postponement after market close on Tuesday. Theravance was up $0.40 to $24.69 on the day.

Breo is a fixed-dose combination of an inhaled corticosteroid and a long-acting adrenergic receptor beta 2 agonist (LABA), which is administered with a dry powder inhaler called Ellipta. The product, which has a May 12 PDUFA date, is under review in the EU under the name Relvar to treat asthma and COPD. ...