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FDA actions

FDA actions

The FDA has approved a new once-daily combination inhaler for the treatment of chronic obstructive pulmonary disease (COPD). The product combines the long-acting beta-agonist (LABA) vilanterol with the steroid fluticasone furoate. Vilanterol is a new LABA and fluticasone furoate is reported to have longer lung retention time compared to the proprionate allowing for once-daily dosing. The product is a dry powder that is delivered via the Ellipta device. The new inhaler was evaluated in 7700 patients with COPD and showed improved lung function and reduced exacerbations compared to placebo. Vilanterol/fluticasone furoate is marketed by GlaxoSmithKline in collaboration with Theravance as Breo Ellipta.