Guselkumab: First Global Approval

Abstract

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.

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Correspondence to Anthony Markham.

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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.

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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. Guselkumab: First Global Approval. Drugs 77, 1487–1492 (2017). https://doi.org/10.1007/s40265-017-0800-7

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