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Vedolizumab: First Global Approval

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Abstract

Vedolizumab [Entyvio® (US, Europe)], a humanized monoclonal antibody α4β7 integrin receptor antagonist, has been developed by Millennium Pharmaceuticals (d/b/a Takeda Pharmaceuticals International) for the treatment of ulcerative colitis and Crohn’s disease. Vedolizumab has received its first global approval for the treatment of ulcerative colitis and Crohn’s disease in the US, for use in adult patients with moderate-to-severe disease who have had an inadequate response, loss of response or intolerance to one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor-α inhibitor) or demonstrated dependence on corticosteroids. Vedolizumab has since been approved for ulcerative colitis and Crohn’s disease in the EU, Norway, Iceland and Liechtenstein. This article summarizes the milestones in the development of vedolizumab leading to its first approval for the treatment of ulcerative colitis and Crohn’s disease.

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References

  1. Lobaton T, Vermeire S, Van Assche G, et al. Review article: anti-adhesion therapies for inflammatory bowel disease. Aliment Pharmacol Ther. 2014;39(6):579–94.

    Article  CAS  PubMed  Google Scholar 

  2. McLean LP, Shea-Donohue T, Cross RK. Vedolizumab for the treatment of ulcerative colitis and Crohn’s disease. Immunotherapy. 2012;4(9):883–98.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  3. Allen PB, Peyrin-Biroulet L. Moving towards disease modification in inflammatory bowel disease therapy. Curr Opin Gastroenterol. 2013;29(4):397–404.

    Article  CAS  PubMed  Google Scholar 

  4. Krishnareddy S, Swaminath A. When combination therapy isn’t working: emerging therapies for the management of inflammatory bowel disease. World J Gastroenterol. 2014;20(5):1139–46.

    CAS  PubMed Central  PubMed  Google Scholar 

  5. Thomas S, Baumgart DC. Targeting leukocyte migration and adhesion in Crohn’s disease and ulcerative colitis. Inflammopharmacology. 2012;20(1):1–18.

    Article  CAS  PubMed  Google Scholar 

  6. Holmes D. Integrin inhibitors go with the gut. Nat Rev Drug Discov. 2013;12(6):411–2.

    Article  CAS  PubMed  Google Scholar 

  7. Cominelli F. Inhibition of leukocyte trafficking in inflammatory bowel disease. N Engl J Med. 2013;369(8):775–6.

    Article  PubMed  Google Scholar 

  8. Milch C, Wyant T, Xu J, et al. Vedolizumab, a monoclonal antibody to the gut homing alpha4beta7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype. J Neuroimmunol. 2013;264(1–2):123–6.

    Article  CAS  PubMed  Google Scholar 

  9. Arihiro S, Ohtani H, Suzuki M, et al. Differential expression of mucosal addressin cell adhesion molecule-1 (MAdCAM-1) in ulcerative colitis and Crohn’s disease. Pathol Int. 2002;52(5–6):367–74.

    Article  CAS  PubMed  Google Scholar 

  10. US Food and Drug Administration. FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease. 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398065.htm. Accessed 5 June 2014.

  11. Takeda Pharmaceuticals America Inc. Prescribing information ENTYVIO (vedolizumab) for injection, for intravenous use. 2014. http://general.takedapharm.com/content/file.aspx?filetypecode=ENTYVIOPI&CountryCode=US&LanguageCode=EN&cacheRandomizer=452533ef-ab7b-4140-922a-a97734127102. Accessed 5 June 2014.

  12. US Food and Drug Administration. BLA approval (BLA 125476/0). 2014. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125476Orig1s000ltr.pdf. Accessed 5 June 2014.

  13. European Medicines Agency. EMA recommends approval of a locally targeted treatment for ulcerative colitis and Crohn’s disease. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/03/WC500163496.pdf. Accessed 5 June 2014.

  14. Takeda. Takeda receives European commission marketing authorisation for Entyvio® (vedolizumab) for the treatment of ulcerative colitis and Crohn’s disease (media release); 28 May 2014. http://www.takeda.com/news/2014/20140528_6590.html.

  15. Takeda Pharmaceutical Company Limited, Millennium Pharmaceuticals Inc. Takeda completes acquisition of millennium (media release); 14 May 2008. http://www.takeda.com.

  16. Millennium Pharmaceuticals Inc. Millennium reports second quarter 2004 financial results (media release); 22 July 2004. http://www.millennium.com.

  17. Wyant T, Yang L, Fedyk E. In vitro assessment of the effects of vedolizumab binding on peripheral blood lymphocytes. mAbs. 2013;5(6):842–50.

    Article  PubMed  Google Scholar 

  18. Feagan BG, Greenberg GR, Wild G, et al. Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin. N Engl J Med. 2005;352(24):2499–507.

    Article  CAS  PubMed  Google Scholar 

  19. Parikh A, Leach T, Wyant T, et al. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis. 2012;18(8):1470–9.

    Article  PubMed  Google Scholar 

  20. Feagan BG, Greenberg GR, Wild G, et al. Treatment of active Crohn’s disease with MLN0002, a humanized antibody to the alpha4beta7 integrin (erratum appears in Clin Gastroenterol Hepatol. 2009;7(4):494). Clin Gastroenterol Hepatol. 2008;6(12):1370–7.

    Article  CAS  PubMed  Google Scholar 

  21. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699–710.

    Article  CAS  PubMed  Google Scholar 

  22. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369(8):711–21.

    Article  CAS  PubMed  Google Scholar 

  23. Wyant T, Leach T, Sankoh S, et al. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut. 2014;. doi:10.1136/gutjnl-2014-307127.

    PubMed  Google Scholar 

  24. Parikh A, Fox I, Leach T, et al. Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2013;19(8):1691–9.

    PubMed  Google Scholar 

  25. Rosario M, Fox I, Milch C, et al. Pharmacokinetic/pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: additional results from GEMINI 1 and 2 (abstract no. P-140). Inflamm Bowel Dis. 2013;19(suppl):S80.

    Article  Google Scholar 

  26. Rosario M, Wyant T, Milch C, et al. Pharmacokinetic and pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: additional results from the GEMINI 1 and 2 studies (abstract no. DOP058). J Crohns Colitis. 2014;8(suppl 1):S42–S43.

  27. Rosario M, Dirks N, Gastonguay M, et al. Population pharmacokinetic modelling of vedolizumab in patients with ulcerative colitis or Crohn’s disease (abstract no. P385). J Crohns Colitis. 2014;8(suppl 1):S225–6.

  28. Dirks NL, Rosario M, Gastonguay MR, et al. Population pharmacokinetic modeling of vedolizumab in patients with ulcerative colitis or Crohn’s disease (abstract no. M01225). Gastroenterology. 2014;1(suppl):S-591.

  29. French J, Rosario M, Dirks NL, et al. Vedolizumab exposure-response relationship during induction therapy in adults with Crohn’s disease (abstract no. Mo1231). Gastroenterology. 2014;1(suppl):S592–3.

    Google Scholar 

  30. French J, Rosario M, Dirks NL, et al. Exposure–response relationship of vedolizumab treatment in adults with ulcerative colitis (abstract no. Mo1229). Gastroenterology. 2014;1(suppl):S-592.

  31. Rosario M, French J, Dirks N, et al. Exposure response relationship during vedolizumab induction therapy in adults with ulcerative colitis (abstract no. P489). J Crohns Colitis. 2014;8 (suppl 1):S270–S271.

  32. Rosario M, French J, Dirks N, et al. Exposure response relationship of vedolizumab after 6 weeks of treatment in adults with Crohn’s disease (abstract no. P488). J Crohns Colitis. 2014;8(suppl 1):S270.

  33. Feagan B, Sands B, Sankoh S, et al. Efficacy of vedolizumab in ulcerative colitis by prior treatment failure in GEMINI I, a randomized, placebo-controlled, double-blind, multicenter trial (abstract no. O-1b). Inflamm Bowel Dis. 2012;18(Suppl. 1):S1–2.

    Article  Google Scholar 

  34. Feagan B, Sandborn WJ, Smyth M, et al. Effects of continued vedolizumab therapy for ulcerative colitis in week 6 induction therapy nonresponders (abstract no. P501). J Crohns Colitis. 2014;8(suppl):S276–7.

  35. Sands B, Hanauer S, Colombel JF, et al. Reductions in corticosteroid use in patients with ulcerative colitis or Crohn’s disease treated with vedolizumab (abstract no. 1676). Am J Gastroenterol. 2013;108(suppl):S503.

    Google Scholar 

  36. Feagan BG, Colombel JF, Rubin DT, et al. Health-related quality of life in patients with ulcerative colitis after treatment with vedolizumab: results from the GEMINI 1 study (abstract no. Mo1223). Gastroenterology. 2014;1(suppl):S-590.

  37. Sandborn WJ, Feagan B, Reinisch W, et al. Efficacy of continued vedolizumab therapy in patients with Crohn’s disease who did not respond to vedolizumab induction therapy at week 6 (abstract no. P497). J Crohns Colitis. 2014;8(suppl):S274–S275.

  38. Hanauer S, Colombel JF, Feagan B, et al. Vedolizumab maintenance therapy for Crohn’s disease: results of GEMINI II, a randomized, placebo-controlled, double-blind, multicenter phase 3 trial (abstract no. 1522). Am J Gastroenterol. 2012;107(suppl):S620–1.

    Google Scholar 

  39. Sands B, Feagan B, Rutgeerts P, et al. Vedolizumab induction therapy for patients with Crohn’s disease and prior anti-TNF antagonist failure: a randomized, placebo-controlled, double-blind, multicenter trial (abstract no. P-26). Inflamm Bowel Dis. 2012;18(Suppl):S24–5.

    Article  Google Scholar 

  40. Feagan BG, McDonald JW, Wild G, et al. An ascending dose trial of a humanized A4B7 antibody in ulcerative colitis (abstract no. 4851). Gastroenterology. 2000;118 (suppl 4 part 1):A874.

  41. Parikh A, Paolino J, Fedy ER, et al. No association between vedolizumab exposure and serum JC virus levels (abstract). J Crohns Colitis. 2011;5 (suppl 1):S109–10.

  42. Millennium Pharmaceuticals. An open-label study of vedolizumab (MLN0002) in patients with ulcerative colitis and Crohn’s disease (GEMINI LTS) (ClinicalTrials.gov identifier NCT00790933). US National Institutes of Health, ClinicalTrials.gov. 2008. http://clinicaltrials.gov/ct2/show/NCT00790933?term=NCT00790933&rank=1. Accessed 9 June 2014.

  43. Takeda. Phase III study of MLN0002 (300 mg) in the treatment of ulcerative colitis (ClinicalTrials.gov identifier NCT02039505). US National Institutes of Health, ClinicalTrials.gov. 2014. http://clinicaltrials.gov/ct2/show/NCT02039505?term=NCT02039505&rank=1. Accessed 9 June 2014.

  44. Takeda. Phase III study of MLN0002 (300 mg) in treatment of Crohn’s disease (ClinicalTrials.gov identifier NCT02038920). US National Institutes of Health, ClinicalTrials.gov. 2014. http://clinicaltrials.gov/ct2/show/NCT02038920?term=NCT02038920&rank=1. Accessed 9 June 2014.

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Authors and Affiliations

  1. Adis, Level 1, 5 The Warehouse Way, Northcote, 0627, Auckland, New Zealand

    Raewyn M. Poole

  2. Adis, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Raewyn M. Poole

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Correspondence to Raewyn M. Poole.

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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.

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Poole, R.M. Vedolizumab: First Global Approval. Drugs 74, 1293–1303 (2014). https://doi.org/10.1007/s40265-014-0253-1

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