FDA panel backs Breo Ellipta for adults, not children

FDA's Pulmonary-Allergy Drugs Advisory and Drug Safety and Risk Management Advisory committees voted 16-4 to recommend approval of Breo Ellipta fluticasone furoate/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) as a once-daily maintenance treatment for asthma in patients aged 18 and older. The committees voted 18-2 against approval for the same indication in children ages 12-17.

The once-daily, fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol administered with the dry powder Ellipta inhaler has an April 30 PDUFA date. ...