Guselkumab (Tremfya™) is a human monoclonal IgG1λ antibody being developed by Janssen Biotech, Inc. that has been approved in the USA as a treatment for moderate-to-severe plaque psoriasis. Guselkumab inhibits the binding of interleukin 23 (IL-23) to its cell surface receptor, disrupting the type 17 helper T cell/IL-17 pathway. This article summarizes the milestones in the development of guselkumab leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Price excludes VAT (USA)
Tax calculation will be finalised during checkout.
Mease PJ. Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis. Curr Opin Rheumatol. 2015;27(2):127–33.
Zhuang Y, Calderon C, Marciniak SJ Jr, et al. First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis. Eur J Clin Pharmacol. 2016;72(11):1303–10.
Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase 3 NAVIGATE trial. Br J Dermatol. 2017. doi:10.1111/bjd.15750
Janssen Biotech Inc. Janssen announces U.S. FDA approval of TREMFYA(T) (guselkumab) for the treatment of moderate to severe plaque psoriasis [media release]. 13 July 2017. http://www.janssen.com.
Janssen Biotech Inc. Janssen submits application to EMA seeking approval of anti-interleukin-23 monoclonal antibody guselkumab for the treatment of moderate to severe plaque psoriasis [media release]. 25 Nov 2016. https://www.jnj.com/media-center/press-releases/janssen-submits-application-to-ema-seeking-approval-of-anti-interleukin-23-monoclonal-antibody-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis.
Janssen Biotech Inc. TREMFYA (guselkumab): prescribing information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf. Accessed 2017.
MorphoSys. MorphoSys announces agreement with Centocor [media release]. 3 Jan 2001. https://www.morphosys.com/media-investors/media-center/morphosys-announces-agreement-with-centocor.
MorphoSys. MorphoSys announces that its licensee Janssen has submitted biologics license application for guselkumab [media release]. 17 Nov 2016. https://www.morphosys.com/media-investors/media-center/morphosys-announces-that-its-licensee-janssen-has-submitted-biologics.
MorphoSys. MorphoSys announces that its licensee Janssen has received US FDA approval for Tremfya(TM) (Guselkumab) for the treatment of moderate to severe plaque psoriasis [media release]. 13 Jul 2017. https://www.morphosys.com/media-investors/media-center/morphosys-announces-that-its-licensee-janssen-has-received-us-fda.
Sofen H, Smith S, Matheson RT, et al. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol. 2014;133(4):1032–40.
Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405–17.
Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418–31.
Ota T, Goto R, Zheng R, et al. Phase 3 study of guselkumab, a human mAb directed against the p19 subunit of IL23, in Japanese subjects with generalized pustular psoriasis and erythrodermic psoriasis [abstract no. 4526]. J Am Acad Dermatol. 2017;76(6 Suppl. 1):AB196.
Gordon KB, Duffin KC, Bissonnette R, et al. A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis. N Engl J Med. 2015;373(2):136–44.
Deodhar A, Gottlieb A, Boehncke WH, et al. Efficacy and safety results of guselkumab, an anti-Il23 monoclonal antibody, in patients with active psoriatic arthritis over 24 weeks: a phase 2A, randomized, double-blind, placebo-controlled study [abstract no. OP0218]. Ann Rheum Dis. 2017;76(Suppl. 2):142–3.
The preparation of this review was not supported by any external funding.
Conflicts of interest
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. Anthony Markham, a contracted employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest. Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/747AF0601856445F.
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.
Rights and permissions
About this article
Cite this article
Markham, A. Guselkumab: First Global Approval. Drugs 77, 1487–1492 (2017). https://doi.org/10.1007/s40265-017-0800-7