FDAnews Drug Daily Bulletin

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

July 17, 2017

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

The drug, according to Jannsen, 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.

View today's stories