title: Umeclidinium/Vilanterol: first global approval.
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.
authors: Adis, Auckland, New Zealand.
authors: Lesley J
authors: LJ
authors: Scott
authors: Philip
authors: P
authors: Hair
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D001592:Benzyl Alcohols / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology; D002722:Chlorobenzenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004338:Drug Combinations; D004347:Drug Interactions; D005541:Forced Expiratory Volume; D006801:Humans; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011812:Quinuclidines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; D004338:Drug Combinations; C573971:GSK573719; D018727:Muscarinic Antagonists; D011812:Quinuclidines; C550468:vilanterol