On July 13, 2017, the Food and Drug Administration (FDA) approved the biologics license application for guselkumab (TREMFYA). The product, a human IgG1 monoclonal antibody targeting interleukin-23, is indicated for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Approval was based on results from a clinical development program that included more than 2,000 patients in the Phase 3 VOYAGE 1, VOYAGE 2 and NAVIGATE studies. Guselkumab was generated using MorphoSys’ Human Combinatorial Antibody Library technology.
As of July 13, guselkumab is the eighth antibody therapeutic to be granted a first marketing approval in any country in 2017, following the approvals of brodalumab, avelumab, ocrelizumab, dupilumab, durvalumab, sarilumab and inotuzumab ozogamicin. The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the EU or US. As of July 13, 2017, marketing applications for a total of nine antibody therapeutics that have not been approved in any country are undergoing review in the EU or US. In addition, a marketing application for the antibody-drug conjugate gemtuzumab ozogamicin, which was approved in 2000 by the US FDA and subsequently withdrawn from the US market, is undergoing review in the EU and US.
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