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FDA panel backs Breo for COPD

April 18, 2013 12:28 AM UTC

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 9-4 that efficacy and safety data for Breo fluticasone furoate/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) support approval of the combination product as a maintenance therapy for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The panel also voted 8-4 to recommend approval to reduce COPD exacerbations. Breo is a fixed-dose combination of an inhaled corticosteroid and vilanterol, a long-acting adrenergic receptor beta 2 agonist (LABA), delivered once-daily via the dry powder Ellipta inhaler.

Panel members felt that the 92-160 mL improvements in FEV1 and 27% reductions in exacerbations seen in the Breo Phase III program were clinically meaningful for patients and that once-daily administration of Breo could provide a dosing advantage over current twice-daily combination products. While there was an increased rate of pneumonia in those receiving Breo in the Phase III program, panel members felt that the rates were comparable to other COPD products containing corticosteroids. ...