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Tremfya FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

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, Psoriatic Arthritis

Tremfya (guselkumab) is an interleukin-23 blocker indicated for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis in adults.

Development Timeline for Tremfya

DateArticle
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

Further information

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