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FDA Approves Stelara for Adolescent Psoriasis

Janssen news release; 2017 Oct 13

Janssen Biotech, Inc., has announced that that the US Food and Drug Administration (FDA) has approved an expanded indication for Stelara (ustekinumab) for the treatment of adolescents (aged ≥12 years) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Janssen Biotech, Inc., is headquartered in Horsham, PA.

Indications: Stelara is a human interleukin-12 and -23 antagonist indicated for the treatment of adolescent patients aged ≥12 years with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.

Dosage/administration: For adolescents aged ≥12 years, weight based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. For less than 60 kg, recommended dosage is 0.75mg/kg; from 60 kg to 100 kg, 45 mg; and >100 kg, 90 mg.

Adverse effects: Most common adverse reactions (≥3%) are nasopharyngitis, upper respiratory tract infection, headache, and fatigue.

Citation:

Janssen announced US FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate to severe plaque psoriasis. [news release]. Horsham, Pennsylvania: Janssen Biotech, Inc. October 13, 2017. https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-stelara-ustekinumab-for-the-treatment-of-adolescents-with-moderate-to-severe-plaque-psoriasis. Accessed November 1, 2017.

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