FDA Approves New Biologic for Plaque Psoriasis
The US Food and Drug Administration (FDA) has recently approved Tremfya (guselkumab) for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This is the first and only biologic therapy that only blocks IL-23, an important cytokine in the pathology of plaque psoriasis, to receive approval from the FDA.
After initiation with 2 starter doses at 0 and 4 weeks, Tremfya is administered at a dose of 100 mg subcutaneously every 8 weeks.
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Approval was based on data from a clinical development program that included over 2000 patients with moderate to severe plaque psoriasis. Patients who were assigned to receive Tremfya experienced significant improvement in skin clearance and symptoms, including itching, pain, stinging, burning, and skin tightness, compared to patients who received placebo at 16 weeks. In comparisons with adalimumab, Tremfya had superior results in skin clearance at 16, 24, and 48 weeks.
Common adverse events association with treatment included upper respiratory infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.
Janssen announces US FDA approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis [press release]. Horsham, PA: Johnson & Johnson; 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 14, 2017.