The Food and Drug Administration (FDA) has approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol; GlaxoSmithKline) for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

Trelegy Ellipta combines fluticasone furoate, an inhaled corticosteroid with umeclidinium, an anticholinergic and vilanterol, a long-acting β2-adrenergic agonist (LABA). The clinical efficacy of Trelegy Ellipta was based primarily on the coadministration of umeclidinium 62.5mcg + fluticasone furoate/vilanterol 100mcg/25mcg in 2 randomized, double-blind, parallel-group, 12-week treatment trials. 

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Trelegy Ellipta is supplied as an inhaler containing 2 foil blisters strips, each with 30 blisters of powder formulation for oral inhalation. One strip contains fluticasone furoate 100mcg per blister and the other contains umeclidinium/vilanterol 62.5mcg/25mcg per blister. A blister from each strip is used to create 1 dose.

The product is expected to be available soon.

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