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FDA Approves Jannsen’s Moderate-to-Severe Psorias Candidate

July 21, 2017

The FDA approved Tremfya (Guselkumab), Jannsen’s drug for treatment of moderate to severe psoriasis.

The drug is the first biologic therapy that blocks IL-23, a cytokine that contributes to plaque psoriasis. The company won approval following an expedited review and receipt of an FDA priority review voucher.

Jannsen submitted Phase III results from a clinical trial involving 2,000 patients that demonstrated significant efficacy. At week 24 of the company’s trials, more than seven out of 10 patients reported at least 90 percent clearer skin.

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