www.fdanews.com/articles/182715-fda-approves-jannsens-moderate-to-severe-psorias-candidate
FDA Approves Jannsen’s Moderate-to-Severe Psorias Candidate
July 19, 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.