FDA approves Janssen’s plaque psoriasis drug Tremfya

SILVER SPRING, Md. — The Food and Drug Adminisration has approved Janssen Biotech’s new treatment for plaque psoriasis, the company announced Thursday. Tremfya (guselkumab) is the first drug to be approved that selectively blocks a key plaque psoriasis cytokine, the company said.

“Addressing the need for additional safe and effective plaque psoriasis therapies has been a critical area of focus at Janssen for more than 15 years,” Janseen VP medical affairs Dr. Andrew Greenspan said. “Considering this, we applied a priority review voucher to the application for Tremfya to bring this novel treatment to patients sooner.”

The drug is indicated for moderate to severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy.

"Living with plaque psoriasis is challenging, especially the constant pain, itching and burning," said Patti Janick, a guselkumab clinical trial participant. "I am encouraged by the results I've experienced with TREMFYA™ and the possibility it offers others living with plaque psoriasis to find similar relief and clearer skin."

Janssen said it would work with payers, providers and pharmacy benefits managers to ensure broad accessibility and affordability for patients, and that the cost for payers is competitive with currently available psoriasis biologic treatments.