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Tremfya Approval History

FDA Approved: Yes (First approved July 13, 2017)
Brand name: Tremfya
Generic name: guselkumab
Dosage form: Injection
Company: Janssen Biotech, Inc.
Treatment for: Plaque Psoriasis

Tremfya (guselkumab) is an interleukin-23 blocker indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Development History and FDA Approval Process for Tremfya

DateArticle
Feb 27, 2019Approval FDA Approves Tremfya (guselkumab) One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis
Jul 13, 2017Approval Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis
Mar  3, 2017New Results From Second Phase 3 Study Show Significant Efficacy of Guselkumab and Superiority Versus Humira in Treatment of Moderate to Severe Plaque Psoriasis
Nov 17, 2016Janssen Submits Application to FDA Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab for the Treatment of Moderate to Severe Plaque Psoriasis
Nov 15, 2016Janssen Next-Generation Biologic Guselkumab Shows Promise in the Treatment of Psoriatic Arthritis in Phase 2 Trial
Oct  1, 2016New Phase 3 Data Show Significant Efficacy Versus Placebo and Superiority of Guselkumab Versus Humira In Treatment of Moderate to Severe Plaque Psoriasis
Jul  9, 2015Phase 2B Findings Published In The NEJM Demonstrate Significant Efficacy Of Guselkumab In Treatment Of Moderate To Severe Plaque Psoriasis
Mar 24, 2014Anti-Interleukin-23 Monoclonal Antibody Guselkumab Shows Significant Efficacy in Treatment of Moderate to Severe Plaque Psoriasis

Further information

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