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Drugs

, Volume 76, Issue 8, pp 901–905 | Cite as

Ixekizumab: First Global Approval

  • Anthony MarkhamEmail author
AdisInsight Report

Abstract

Ixekizumab (Taltz®) is a humanised monoclonal immunoglobulin G antibody developed by Eli Lilly and Company that has been approved in the USA as a treatment for plaque psoriasis. Ixekizumab is a specific inhibitor of interleukin-17A (IL-17A), a pro-inflammatory cytokine that has a role in the development of several inflammatory conditions. This article summarizes the milestones in the development of ixekizumab leading to this first approval for plaque psoriasis.

Keywords

Psoriasis Etanercept Placebo Recipient Psoriatic Arthritis Plaque Psoriasis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Compliances with Ethical Standards

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis, Springer SBM.

References

  1. 1.
    Eli Lilly and Company. TALTZ(TM) (ixekizumab): US prescribing information. Indianapolis: Eli Lilly and Company; 2016.Google Scholar
  2. 2.
    European Medicine Agency. CHMP summary of positive opinion for Taltz 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003943/WC500202360.pdf. Accessed 29 Feb 2016.
  3. 3.
    Krueger JG, Fretzin S, Suarez-Farinas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130(1):145–54.e9.Google Scholar
  4. 4.
    Duffin KC, Bagel J, Bukhalo M, et al. Comparison of the pharmacokinetics of ixekizumab following subcutaneous administration using a prefilled syringe versus an autoinjector in patients with moderate-to-severe psoriasis over 12 weeks [abstract no. 2857 plus poster]. In: 74th Annual Meeting of the American Academy of Dermatology; 2016.Google Scholar
  5. 5.
    Gordon K, Blauvelt A, Langley R, et al. Ixekizumab for treatment of moderate-to-severe plaque psoriasis: 60-week results from a double-blind phase 3 induction and randomized withdrawal study (UNCOVER-1) [abstract no. F010]. In: American Academy of Dermatology; 2015.Google Scholar
  6. 6.
    Griffiths CEM, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541–51.CrossRefPubMedGoogle Scholar
  7. 7.
    Papp K, Weisman J, Puig L, et al. Ixekizumab shows efficacy and safety in patients who failed bi-weekly etanercept therapy: analysis from UNCOVER-2, a phase 3 randomized clinical trial in psoriasis [abstract no. 3017]. In: American Academy of Dermatology; 2016.Google Scholar
  8. 8.
    Papp K, Leonardi C, Blauvelt A, et al. Efficacy of ixekizumab therapy: integrated analysis of 3 double-blind, controlled trials (UNCOVER-1, UNCOVER-2, UNCOVER-3) [abstract no. 3031 plus poster]. In: 74th Annual Meeting of the American Academy of Dermatology; 2016.Google Scholar
  9. 9.
    Saeki H, Nakagawa H, Ishii T, et al. Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. J Eur Acad Dermatol Venereol. 2015;29(6):1148–55.CrossRefPubMedGoogle Scholar
  10. 10.
    Leonardi C, Matheson R, Zachariae C, et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med. 2012;366:1190–9.CrossRefPubMedGoogle Scholar
  11. 11.
    Gordon KB, Leonardi CL, Lebwohl M, et al. A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2014;71:1176–82.CrossRefPubMedGoogle Scholar
  12. 12.
    McKevitt N, Armstrong A, Lebwohl M, et al. Effects of ixekizumab treatment on quality of life during 48 weeks of open-label treatment in a phase-2 trial in psoriasis [abstract]. Australas J Dermatol. 2015;56(Suppl 2):50–1.Google Scholar
  13. 13.
    Richter S, Edson-Heredia E, Zhu B, et al. A >90 % PASI response is associated with improved patient reported outcomes: phase 2 study results for ixekizumab-treated psoriasis patients [abstract]. Australas J Dermatol. 2014;55(Suppl 1):46.Google Scholar
  14. 14.
    Mease PJ, van der Heijde D, Ritchlin CT, et al. Efficacy of ixekizumab in patients with psoriatic arthritis: results of a phase 3 randomized, double-blind, active- and placebo-controlled study [abstract no. 2515 plus poster]. In: 74th Annual Meeting of the American Academy of Dermatology; 2016.Google Scholar
  15. 15.
    Gottlieb AB, Mease PJ, Cuchacovich RS, et al. Ixekizumab improves physical function, quality of life, and work productivity in biologic disease-modifying antirheumatic drug-naive patients with active psoriatic arthritis [abstract no. 2145]. Arthritis Rheumatol. 2015;67(Suppl 10).Google Scholar
  16. 16.
    Genovese MC, Greenwald M, Cho CS, et al. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2014;66(7):1693–704.CrossRefPubMedGoogle Scholar
  17. 17.
    Genovese MC, Braun DK, Erickson JS, et al. Safety and efficacy of open-label subcutaneous ixekizumab treatment for 48 weeks in a phase II study in biologic-naive and TNF-IR patients with rheumatoid arthritis. J Rheumatol. 2016;43(2):289–97.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

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