Olodaterol: First global approval

Drugs

Volumn 73, Issue 16, 2013, Pages 1841-1846

  Gibb, Andrew ^a   Yang, Lily P H ^b  

^a Adis R and D Insight   (New Zealand)

^b ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

CICLESONIDE; DIURETIC AGENT; FORMOTEROL; KETOCONAZOLE; MONOAMINE OXIDASE INHIBITOR; OLODATEROL; PLACEBO; RESPIMAT; STEROID; STRIVERDI; TIOTROPIUM BROMIDE; TRICYCLIC ANTIDEPRESSANT AGENT; UNCLASSIFIED DRUG; XANTHINE DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; ASTHMA; CHRONIC OBSTRUCTIVE LUNG DISEASE; DOSAGE SCHEDULE COMPARISON; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG POTENTIATION; DRUG RECEPTOR BINDING; FORCED EXPIRATORY VOLUME; HEART VENTRICLE ARRHYTHMIA; HUMAN; HYPOKALEMIA; LUNG CANCER; LUNG SMALL CELL CANCER; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PNEUMONIA; RHINOPHARYNGITIS; SINGLE DRUG DOSE; SUDDEN CARDIAC DEATH; UPPER RESPIRATORY TRACT INFECTION;

ADMINISTRATION, INHALATION; ASTHMA; BENZOXAZINES; BRONCHODILATOR AGENTS; CLINICAL TRIALS, PHASE II AS TOPIC; HUMANS; NEBULIZERS AND VAPORIZERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SCOPOLAMINE DERIVATIVES;

EID: 84888989992     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0137-9     Document Type: Article

References (41)

1. 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 Respir Crit Care Med. 2013;187(4):347-65.
2. Cazzola M, Page CP, Calzetta L, et al. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev. 2012;64(3):450-504.
3. Health Canada. Summary basis of decision (SBD) for Striverdi Respimat (olodaterol hydrochloride); 9 Aug 2013. http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/sbd-smd/drug-med/sbd-smd-2013
4. Joos G, Aumann JL, Coeck C, et al. Comparison of 24-hour FEV1 profile for once-daily versus twice-daily treatment with olodaterol, a novel long-acting B2-agonist, in patients with COPD [abstract no. A2930]. Am J Respir Crit Care Med. 2012;185(Abstract issue).
5. 2-adrenoceptor agonist exerting a 24-hour-long duration of action in preclinical models. J Pharmacol Exp Ther. 2010;334(1):53-62.
6. Brown SM, Barnes PJ, Donnelly LE. Effect of olodaterol on the relaxation of small airways [abstract]. 2011 Annual Congress of the European Respiratory Society; 24-28 Sep 2011; Amsterdam.
7. 2- subtype of adrenoceptors mediates inhibition of pro-fibrotic events in human lung fibroblasts. Naunyn-Schmiedeberg's Arch Pharmacol. 2011;384(2):133-45.
8. Racké K, Warnken M, Ahmedat AS, et al. The long acting beta2-adrenoceptor agonist olodaterol mediates inhibition of prepro-endothelin-1 expression in human lung fibroblasts [abstract no. A6053]. Am J Respir Crit Care Med. 2011;183(Abstracts issue).
9. Lewis R, Chachi Y, Amrani P. A comparison of B2-adrenoceptor desensitisation induced by olodaterol and formoterol in human lung mast cells and airway smooth muscle cells [abstract no. P1589]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
10. Naline E, Ostermann A, Devillier P, et al. β2 agonist intrinsic activity: comparison of BI 1744 and formoterol in different functional settings [abstract no. A4443]. Am J Respir Crit Care Med. 2010;181(Abstracts issue).
11. Casarosa P, Kollak I, Kiechle T, et al. Functional and biochemical rationales for the 24-hour-long duration of action of olodaterol. J Pharmacol Exp Ther. 2011;337(3):600-9.
12. van Noord JA, Smeets JJ, Drenth BM, et al. 24-hour bronchodilation following a single dose of the novel β(2)-agonist olodaterol in COPD. Pulm Pharmacol Ther. 2011;24(6):666-72.
13. O'Byrne PM, van der Linde J, Cockcroft DW, et al. Prolonged bronchoprotection against inhaled methacholine by inhaled BI 1744, along-acting beta(2)-agonist, in patients with mild asthma. J Allergy Clin Immunol. 2009;124:1217-21.
14. van Noord JA, Korducki L, Hamilton AL. Four weeks once daily treatment with BI 1744 CL, a novel long-acting beta-2-agonist, is effective in COPD patients [abstract no. A6183]. Am J Respir Crit Care Med. 2009;179(Abstracts issue).
15. Troost J, Pivovarova A, Kunz C, et al. Evaluation of the effects of the long-acting β2-agonist olodaterol on the Qt and Qtc interval in healthy subjects [abstract no. A2603]. Am J Respir Crit Care Med. 2013;187(Abstracts issue).
16. Profita M, Albano GD, Montalbano AM, et al. Acetylcholine leads to signal transducer and activator of transcription 1 (STAT-1) mediated oxidative/nitrosative stress in human bronchial epithelial cell line. Biochim Biophys Acta Mol Basis Dis. 2013;1832(12):1949-58.
17. Profita M, Bonanno A, Montalbano AM, et al. β2 long-acting and anticholinergic drugs control TGF-β1-mediated neutrophilic inflammation in COPD. Biochim Biophys Acta. 2012;1822(7):1079-89.
18. Bouyssou T, Schnapp A, Casarosa P, et al. Addition of the new once-daily LABA BI 1744 to tiotropium results in superior bronchoprotection in pre-clinical models [abstract no. A4448]. Am J Respir Crit Care Med. 2010;181(Abstracts issue).
19. Schlepütz M, Maihöfer N, Rieg AD, et al. Combination study of tiotropium and olodaterol in human precision-cut lung slices [abstract]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
20. Meurs H, Smit M, Zuidhof AB, et al. The bronchoprotective effect of olodaterol against histamine is synergistically enhanced and prolonged by tiotropium bromide [abstract no. A1379]. Am J Respir Crit Care Med. 2011;183(Abstracts issue).
21. Smit M, Zuidhof A, Bos S, et al. Protection against allergen-induced airway hyperresponsiveness (AHR) by olodaterol in guinea pigs is synergistically enhanced by tiotropium [abstract]. 2012 Annual Congress of the European Respiratory Society; 1-5 Sep 2012; Vienna.
22. Smit M, Zuidhof AB, Bos IST, et al. Acute reversal of allergen-induced airway hyperresponsiveness (AHR) by olodaterol is synergistically enhanced by tiotropium bromide [abstract]. 2011 Annual Congress of the European Respiratory Society; 24-28 Sep 2011; Amsterdam.
23. Costa L, Roth M, Tamm M, et al. Tiotropium enhances the inhibitory effect of the long acting β2-agonist olodaterol on the release of IL-6 and IL8 by primary human lung fibroblasts of asthma patients [abstract]. 2012 Annual Congress of the European Respiratory Society; 1-5 Sep 2012; Vienna.
24. Costa L, Roth M, Tamm M, et al. Tiotropium and olodaterol exert anti-proliferative effects on pulmonary fibroblasts of asthmatic patients in vitro [abstract no. P571]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
25. 3 antagonist) and ciclesonide (inhaled steroid) on the ovalbumin-induced bronchoconstriction in anaesthetized guinea pigs [abstract]. 2011 Annual Congress of the European Respiratory Society; 24-28 Sep 2011; Amsterdam.
26. ® in COPD patients: results from two 48-week studies [abstract no. 187]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
27. ® vs placebo and formoterol BID in patients with COPD: two 48-week studies [abstract no. P764 plus poster]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
28. ® vs placebo and formoterol BID in patients with COPD: combined analysis from two 48-week studies [abstract no. P763]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
29. Tucker ME. FDA panel votes in favor of olodaterol for COPD; 30 Jan 2013. http://www.medscape.com/viewarticle/778459 (Accessed 20 Sep 2013).
30. ® in COPD: results from two 6-week studies [abstract no. 4635]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
31. Ichinose M, Takizawa A, Izumoto T. Efficacy of 4 weeks' once-daily treatment with olodaterol (BI 1744), a novel long-acting B2-agonist, in Japanese patients with COPD [abstract no. A2931]. Am J Respir Crit Care Med. 2012;185(Abstract issue).
32. US FDA. Pulmonary Allergy Drugs Advisory Committee Meeting: olodaterol inhalation spray NDA 203108; 29 Jan 2013. http://www.fda.gov/downloads/ advisorycommittees/committeesmeetingmaterials/drugs/pulmonary- allergydrugsadvisorycommittee/ucm337987.pdf (Accessed 23 Sep 2013).
33. Beeh KM, Beck E, Gahlemann M, et al. Dose-finding study of 4-week, once-daily treatment with olodaterol, a novel long-acting B2-agonist, in patients with asthma [abstract no. A2764]. Am J Respir Crit Care Med. 2012;185(Abstract issue).
34. O'Byrne PM, D'Urzo T, Gahlemann M, et al. Dose-finding study of once-daily treatment with olodaterol, a novel long-acting B2-agonist, in patients with asthma [abstract no. A3963]. Am J Respir Crit Care Med. 2012;185(Abstract issue).
35. Boehringer Ingelheim GmbH. New data show significant improvements in lung function using combination of tiotropium and olodaterol in COPD patients [media release]; 3 Sep 2013. http://www.boehringer-ingelheim.com/news/news-releases/ press-releases/2012/03-september-2012-copd.html.
36. ® inhaler in patients with COPD [abstract no. P2882]. 22nd Annual Congress of the European Respiratory Society; 1-5 Sep 2012; Vienna.
37. Maltais F, Beck E, Webster D, et al. Four weeks once daily treatment with tiotropium + olodaterol (BI1744) fixed dose combination compared with tiotropium in COPD patients [abstract no. 5557]. 20th Annual Congress of the European Respiratory Society; 18-22 Sep 2013; Barcelona.
38. Jenkins CR. More than just reassurance on tiotropium safety. N Engl J Med. 2013;369(16):1555-6.
39. Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369(16):1491-501.
40. ® vs placebo and formoterol BID in patients with COPD: pooled safety analysis [abstract no. P3633]. 2013 Annual Congress of the European Respiratory Society; 7-11 Sep 2013; Barcelona.
41. ® provides effective and sustained improvements in lung function in patients with COPD [media release]; 9 Sep 2013. http://www.boehringer-ingelheim.com/news/news-releases/press-releases/2013/09- september-2013olodaterol.html.