Umeclidinium/vilanterol: First global approval

Drugs

Volumn 74, Issue 3, 2014, Pages 389-395

  Scott, Lesley J ^b   Hair, Philip ^a  

^a Adis R and D Insight   (New Zealand)

^b ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ADRENERGIC RECEPTOR STIMULATING AGENT; BETA 2 ADRENERGIC RECEPTOR; CHOLINERGIC RECEPTOR BLOCKING AGENT; CYTOCHROME P450 INHIBITOR; FLUTICASONE PROPIONATE PLUS SALMETEROL; MONOAMINE OXIDASE INHIBITOR; MUSCARINIC RECEPTOR; PLACEBO; THIAZIDE DIURETIC AGENT; TIOTROPIUM BROMIDE; TRICYCLIC ANTIDEPRESSANT AGENT; UMECLIDINIUM; UMECLIDINIUM PLUS VILANTEROL; VILANTEROL; BENZYL ALCOHOL DERIVATIVE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CHLOROBENZENE; DRUG COMBINATION; MUSCARINIC RECEPTOR BLOCKING AGENT; QUINUCLIDINE DERIVATIVE;

ABDOMINAL PAIN; AIRWAY OBSTRUCTION; ARTHRALGIA; BACKACHE; BRONCHODILATATION; CANADA; CARDIOVASCULAR EFFECT; CHRONIC BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONSTIPATION; COUGHING; DIABETES MELLITUS; DIARRHEA; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG APPROVAL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG INTERACTION; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; HEART ATRIUM ARRHYTHMIA; HUMAN; LIMB PAIN; LOWER RESPIRATORY TRACT INFECTION; LUNG EMPHYSEMA; MAINTENANCE THERAPY; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY (TOPIC); MUSCLE SPASM; NAUSEA; NECK PAIN; NONHUMAN; PHARYNGITIS; PHASE 3 CLINICAL TRIAL (TOPIC); PLEURAL PAIN; REVIEW; SINUSITIS; THORAX PAIN; TOOTH PAIN; UNITED STATES; URINARY TRACT INFECTION; VERTIGO; VIRAL RESPIRATORY TRACT INFECTION; CLINICAL TRIAL (TOPIC); DRUG COMBINATION; FORCED EXPIRATORY VOLUME; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE;

ADRENERGIC BETA-2 RECEPTOR AGONISTS; BENZYL ALCOHOLS; CHLOROBENZENES; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG COMBINATIONS; DRUG INTERACTIONS; FORCED EXPIRATORY VOLUME; HUMANS; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINUCLIDINES;

EID: 84895816480     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0186-8     Document Type: Review

References (25)

1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2013. http://www.goldcopd.org/. Accessed 9 Jan 2014.
2. Vestbo J, Hurd SS, Agusti AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Resp Crit Care Med. 2013;187(4):347-65.
3. US Food and Drug Administration. FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease. 2013. http://www.fda.gov/newsevents/ newsroom/pressannouncements/ucm379057.htm. Accessed 10 Jan 2014.
4. GlaxoSmithKline Inc. Anoro Ellipta approved for COPD in Canada [media release]. 2014. http://www.firstwordpharma.com/node/1177487?tsid=28®ion- id=3#axzz2qDDGAfxx. Accessed 13 Jan 2014.
5. Theravance Inc, GlaxoSmithKline plc. GlaxoSmithKline to increase its shareholding in Theravance [media release]. 2010. http://www.gsk.com/media/ press-releases/2010/glaxosmithkline-to-increase-its-shareholding-in-theravance. html. Accessed 9 Jan 2014.
6. GlaxoSmithKline plc, Theravance Inc. GSK and Theravance announce regulatory submission for Anoro™ Ellipta™ (UMEC/VI) in Japan [media release]. 2013. http://www.gsk.com/media/press-releases/2013/gsk-and-theravance- announce-regulatory-submission-for-anoro-elli.html. Accessed 10 Jan 2014.
7. GlaxoSmithKline. Anoro Ellipta (umeclidinium and vilanterol) inhalation powder: USA prescribing information. 2014. http://www.rxlist.com/anoro-ellipta- drug.htm. Accessed 9 Jan 2014.
8. GlaxoSmithKline. A multicenter, trial comparing the efficacy and safety of umeclidinium/vilanterol 62.5/25 μg once daily with tiotropium 18 μg once daily over 24 weeks in subjects with chronic obstructive pulmonary disease (COPD) [ClinicalTrials.gov identifier NCT01777334]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov. Accessed 20 Dec 2013.
9. GlaxoSmithKline. A 52 week study to evaluate the safety and tolerability of GSK573719/GW642444 125 μg once-daily alone and in combination with GW642444 25 μg once-daily via novel dry powder inhaler (nDPI) in Japanese subjects with chronic obstructive pulmonary disease [ClinicalTrials.gov identifier NCT01376388]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov. Accessed 12 Dec 2013.
10. Salmon M, Luttmann MA, Foley JJ, et al. Pharmacological characterization of GSK57319 (umeclidinium): a novel, long-acting, inhaled antagonist of the muscarinic receptors for treatment of pulmonary disease. J Pharmacol Exp Ther. 2013;345(2):260-70.
11. 2- adreneroreceptor agonist with 24-hour duration of action. J Pharmacol Exp Ther. 2013;344(1):218-30.
12. Kelleher D, Tombs L, Crater G, et al. A placebo- and moxifloxacin- controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects [abstract]. AmJ Respir Crit Care Med. 2013;187:A1487.
13. Goyal N, Beerahee M, Kalberg C, et al. Population pharmacokinetics of umeclidinium and vilanterol in patients with COPD [abstract no. 1708416]. Clin Pharmacol Drug Dev. 2013;2(Suppl. 1):28.
14. Kelleher DL, Mehta RS, Jean-Francois BM, et al. Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial. PLoS ONE. 2012;7(12):e50716.
15. Mehta R, Hardes K, Kelleher D, et al. Effect of moderate hepatic impairment (MHI) on umeclidinium (UMEC) and vilanterol (VI) pharmacokinetics (PK) [abstract no. P3641]. In: 23rd Annual congress of the European Respiratory Society, Barcelona, 7-11 Sep 2013.
16. Kelleher D, Hardes K, Brealey N, et al. Effect of severe renal impairment (SRI) on umeclidinium (UMEC) and vilanterol (VI) pharmacokinetics (PK) [abstract no. P4148]. In: 23rd Annual congress of the European Respiratory Society, Barcelona, 7-11 Sep 2013.
17. Mehta R, Kelleher D, Preece A, et al. Effect of verapamil on systemic exposure and safety of umeclidinium and vilanterol: a randomized and open-label study. Int J COPD. 2013;8:159-67.
18. Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25mcg inCOPD. Respir Med. 2013;107(10):1538-46.
19. Celli BR, Crater G, Kilbride S, et al. A 24-week randomized, double-blind, placebo-controlled study of the efficacy and safety of once-daily umeclidinium/vilanterol 125/25 mcg in COPD [abstract]. Am J Respir Crit Care Med. 2013;187:A2435.
20. GlaxoSmithKline. Pulmonary Allergy Drugs Advisory Committee Meeting: FDA briefing document. NDA 203-975: umeclidinium and vilanterol inhalation powder for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). 2013. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/ drugs/pulmonary-allergydrugsadvisorycommittee/ucm367411.pdf. Accessed 10 Jan 2014.
21. Anzueto A, Decramer M, Kaelin T, et al. The efficacy and safety of umeclidinium/vilanterol compared with tiotropium or vilanterol over 24 weeks in subjects with COPD [abstract]. Am J Respir Crit Care Med. 2013;187:A4268.
22. GlaxoSmithKline. DB2113374: a multicenter trial comparing the efficacy and safety of GSK573719/GW642444 with GSK573719 and with tiotropium over 24 weeks in subjects with chronic obstructive pulmonary disease (COPD) [ClinicalTrials.gov identifier NCT01316913]. US National Institutes of Health, ClinicalTrials.gov 2013. http://www.clinicaltrials.gov. Accessed 20 Dec 2013.
23. Maltais F, Singh S, Donald A, et al. Effects of a combination of vilanterol and umeclidinium on exercise endurance in subjects with COPD: two randomised clinical trials [abstract no. P761]. In: 23rd Annual congress of the European Respiratory Society, Barcelona, 7-11 Sep 2013.
24. Riley J, Tabberer M, Richard N, et al. Use of a new dry powder inhaler to deliver umeclidinium/vilanterol in the treatment of COPD [abstract no. P4145]. In: 23rd Annual congress of the European Respiratory Society, Barcelona, 7-11 Sep 2013.
25. Donohue J, Niewoehner D, Brooks J, et al. Long-term safety and tolerability of umeclidinium/vilanterol and umeclidinium in COPD [abstract no. P760]. In: 23rd Annual congress of the European Respiratory Society, Barcelona, 7-11 Sep 2013.