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Umeclidinium/Vilanterol: first global approval.

Research paper by Lesley J LJ Scott, Philip P Hair

Indexed on: 18 Feb '14Published on: 18 Feb '14Published in: Drugs



Abstract

Umeclidinium/vilanterol (Anoro™ Ellipta™ [USA; Canada; proposed Japan]; Anoro™ [proposed EU]), an inhaled fixed-dose combination of a long-acting muscarinic antagonist and a long-acting β2-adrenergic agonist, is indicated for once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium/vilanterol received its first global approval in this indication in the USA and has subsequently been approved for use in the same indication in Canada, with submissions for regulatory approval in patients with COPD under review elsewhere, including in Europe and Japan. This article summarizes the milestones in the development of umeclidinium/vilanterol leading to its first approval for maintenance treatment of airflow obstruction in patients with COPD.