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Literature DB >> 24532124

Umeclidinium/Vilanterol: first global approval.

Lesley J Scott¹, Philip Hair.
1. Adis, Auckland, New Zealand.

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.

Entities: Chemical Disease Gene Species

Mesh：

Substances：

Year: 2014 PMID： 24532124 DOI： 10.1007/s40265-014-0186-8

Source DB: PubMed Journal: Drugs ISSN： 0012-6667 Impact factor: 9.546

6 in total

1. Pharmacological characterization of GSK573719 (umeclidinium): a novel, long-acting, inhaled antagonist of the muscarinic cholinergic receptors for treatment of pulmonary diseases.

Authors: Michael Salmon; Mark A Luttmann; James J Foley; Peter T Buckley; Dulcie B Schmidt; Miriam Burman; Edward F Webb; Christopher J DeHaas; Charles J Kotzer; Victoria J Barrett; Robert J Slack; Henry M Sarau; Michael R Palovich; Dramane I Lainé; Douglas W P Hay; William L Rumsey
Journal: J Pharmacol Exp Ther Date: 2013-02-22 Impact factor: 4.030

2. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD.

Authors: J F Donohue; M R Maleki-Yazdi; S Kilbride; R Mehta; C Kalberg; A Church
Journal: Respir Med Date: 2013-07-02 Impact factor: 3.415

Review 3. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary.

Authors: Jørgen Vestbo; Suzanne S Hurd; Alvar G Agustí; Paul W Jones; Claus Vogelmeier; Antonio Anzueto; Peter J Barnes; Leonardo M Fabbri; Fernando J Martinez; Masaharu Nishimura; Robert A Stockley; Don D Sin; Roberto Rodriguez-Roisin
Journal: Am J Respir Crit Care Med Date: 2012-08-09 Impact factor: 21.405

4. In vitro pharmacological characterization of vilanterol, a novel long-acting β2-adrenoceptor agonist with 24-hour duration of action.

Authors: Robert J Slack; Victoria J Barrett; Valerie S Morrison; Richard G Sturton; Amanda J Emmons; Alison J Ford; Richard G Knowles
Journal: J Pharmacol Exp Ther Date: 2012-11-06 Impact factor: 4.030

5. Effect of verapamil on systemic exposure and safety of umeclidinium and vilanterol: a randomized and open-label study.

Authors: Rashmi Mehta; Dennis Kelleher; Andrew Preece; Stephen Hughes; Glenn Crater
Journal: Int J Chron Obstruct Pulmon Dis Date: 2013-03-27

6. Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial.

Authors: Dennis L Kelleher; Rashmi S Mehta; Bernadette M Jean-Francois; Andrew F Preece; James Blowers; Glenn D Crater; Paul Thomas
Journal: PLoS One Date: 2012-12-17 Impact factor: 3.240

6 in total

4 in total

Review 1. Umeclidinium/vilanterol: a review of its use as maintenance therapy in adults with chronic obstructive pulmonary disease.

Authors: Hannah A Blair; Emma D Deeks
Journal: Drugs Date: 2015-01 Impact factor: 9.546