Breo blazes a trail

Breo fluticasone furoate/vilanterol from GlaxoSmithKline plc and Theravance Inc. is the first combination product containing a LABA to come before FDA with the benefit of a development program that was prospectively designed to address safety concerns that have dogged the LABA class since 2008. If the agency follows an advisory committee vote recommending approval of Breo, the partners' large and complex development program could set the benchmark for other LABAs for COPD.

Breo is a once-daily fixed-dose combination of the inhaled corticosteroid fluticasone and the long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol...