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FDA Approves Tremfya for Plaque Psoriasis

Janssen Biotech Inc. news release; 2017 Jul 13

Janssen Biotech, Inc. (Janssen) has announced that the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of plaque psoriasis. In the US, Janssen Biotech, Inc. is headquartered in Horsham, PA; Raritan, NJ; and Titusville, NJ.

Indications: Tremfya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Dosage/administration: Tremfya is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. It is intended for use under the guidance and supervision of a physician. Patients may self-inject with Tremfya after physician approval and proper training.

Adverse reactions: Most common (≥1%) adverse reactions associated with Tremfya include upper respiratory infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

Citation:

Janssen announces US FDA approval of Tremfya™ (guselkumab) for the treatment of moderate to severe plaque psoriasis. [news release]. Horsham, PA: Janssen Biotech, Inc. July 13, 2017. https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-tremfya-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis. Accessed July 19, 2017.