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Ixekizumab: First Global Approval

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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.

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References

  1. Eli Lilly and Company. TALTZ(TM) (ixekizumab): US prescribing information. Indianapolis: Eli Lilly and Company; 2016.

    Google Scholar 

  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. 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.

  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.

  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.

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

  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.

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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. 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. 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.

  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).

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

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Correspondence to Anthony Markham.

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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.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A. Ixekizumab: First Global Approval. Drugs 76, 901–905 (2016). https://doi.org/10.1007/s40265-016-0579-y

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