Skip to main content
SpringerLink
Log in

Olodaterol: First Global Approval

  • R&D Insight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Olodaterol (Striverdi® Respimat®) is a novel, long-acting, β2-adrenergic receptor agonist developed by Boehringer Ingelheim for the treatment of chronic obstructive pulmonary disease (COPD). The drug is delivered via the Respimat® Soft Mist™ inhaler. Olodaterol received its first global approval for the once-daily maintenance treatment of COPD in Canada and Russia, and submissions for regulatory approval have also been made in the USA, the EU and elsewhere. Phase II trials have been conducted in patients with asthma. The company is also developing a fixed-dose combination of olodaterol with tiotropium bromide, a long-acting anti-muscarinic agent, for the treatment of COPD. This article summarizes the milestones in the development of olodaterol leading to this first approval for COPD.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  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.

    Article  PubMed  CAS  Google Scholar 

  2. Cazzola M, Page CP, Calzetta L, et al. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev. 2012;64(3):450–504.

    Article  PubMed  CAS  Google Scholar 

  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_striverdi_respimat_155649-eng.php (Accessed 20 Sep 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. Bouyssou T, Casarosa P, Naline E, et al. Pharmacological characterization of olodaterol, a novel inhaled β2-adrenoceptor agonist exerting a 24-hour-long duration of action in preclinical models. J Pharmacol Exp Ther. 2010;334(1):53–62.

    Article  PubMed  CAS  Google Scholar 

  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. Lamyel F, Warnken-Uhlich M, Seemann WK, et al. The β2-subtype of adrenoceptors mediates inhibition of pro-fibrotic events in human lung fibroblasts. Naunyn-Schmiedeberg’s Arch Pharmacol. 2011;384(2):133–45.

    Article  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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. Bouyssou T, Casarosa P, Pieper M, et al. Synergistic bronchoprotective activity of the long-acting beta 2-agonist olodaterol with tiotropium (long-acting M3 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. Ferguson G, Feldman G, Hofbauer P, et al. Lung function efficacy of olodaterol QD delivered via Respimat® 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. Koch A, Pizzichini E, Hamilton A, et al. Lung function efficacy of olodaterol QD delivered via Respimat® 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. Koch A, Paggiaro P, Hamilton A, et al. Symptomatic benefit of olodaterol QD delivered via Respimat® 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. Lange P, Aumann JL, Derom E, et al. The 24-h FEV1 time profile of olodaterol QD delivered via Respimat® 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. Aalbers R, Maleki-Yazdi MR, Hamilton A, et al. Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat® 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.

    Google Scholar 

  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.

    Google Scholar 

  40. McGarvey L, Koch A, Sachs P, et al. 48-week administration of olodaterol QD via Respimat® 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. Boehringer Ingelheim GmbH. ERS Congress 2013. Phase III results: once daily olodaterol Respimat® 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.

Download references

Author information

Authors and Affiliations

  1. Adis R&D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Andrew Gibb

  2. Adis, Auckland, New Zealand

    Lily P. H. Yang

Authors
  1. Andrew Gibb
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lily P. H. Yang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Andrew Gibb.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Gibb, A., Yang, L.P.H. Olodaterol: First Global Approval. Drugs 73, 1841–1846 (2013). https://doi.org/10.1007/s40265-013-0137-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-013-0137-9

Keywords

Search

Navigation