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Tremfya FDA Approval History

FDA Approved: Yes (First approved July 13, 2017)
Brand name: Tremfya
Generic name: guselkumab
Dosage form: Injection
Company: Johnson & Johnson Innovative Medicine
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Ulcerative Colitis, Crohn's Disease

Tremfya (guselkumab) is an interleukin-23 blocker for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.

Development timeline for Tremfya

DateArticle
Mar 20, 2025Approval FDA Approves Tremfya (guselkumab) for Adult Patients with Moderately to Severely Active Crohn’s Disease
Sep 13, 2024Approval Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis
Jul 14, 2020Approval Tremfya (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
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
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

See also

Tremfya (guselkumab) Consumer information

Further information

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