The U.S. Food and Drug Administration (FDA) has approved Janssen Biotech’s Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Tremfya is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis, the company said.
Approval comes after an expedited regulatory review following application of an FDA Priority Review Voucher. Tremfya is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4.
The company said that in clinical studies, patients receiving Tremfya experienced significant improvement in skin clearance and greater improvement in symptoms of plaque psoriasis including
itch, pain, stinging, burning and skin tightness when compared with placebo at week 16. Superior results in skin clearance (PASI 90) were demonstrated with Tremfya compared with Humira (adalimumab) at
weeks 16, 24 and 48.
“Tremfya represents a significant milestone in the treatment of moderate to severe plaque psoriasis as
evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23– specific therapy at week 16 and up to week 48,” said Andrew Blauvelt, M.D., M.B.A., President of Oregon Medical Research Center, and study investigator. “We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease, which is another reason why today’s approval of Tremfya is exciting, both as a researcher and a practicing dermatologist.”