Janssen Biotech'smonoclonal antibody TREMFYA (guselkumab) is approved by the FDA.
Adults suffering from moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy will soon have a new biologic treatment option. The FDA has approved TREMFYA (guselkumab), a monoclonal antibody developed by Janssen Biotech, a business unit of Johnson & Johnson that binds to interleukin 23 (IL-23), a pro-inflammatory cytokine.
In March 2017, Janssen reported successful results for guselkumab in VOYAGE 2 and NAVIGATE, two Phase III clinical trials comparing the performance of the drug against a placebo and AbbVie's Humira (adalimumab). Seven out of 10 patients taking TREMFYA experienced at least a 90% improvement in skin clearance after 16 weeks, and nearly 75% had similar results after 48 weeks. In addition, TREMFYA provided better skin clearance compared to Humira after 16, 24 and 48 weeks.
The monoclonal antibody is the only approved biologic that blocks only IL-23, according to the company. This cytokine is known to play a key role in plaque psoriasis. "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."
Noted Andrew Greenspan, M.D., Vice President of Medical Affairs at Janssen: "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. Considering this, we applied a priority review voucher to the application for TREMFYA™ to bring this novel treatment to patients sooner."
J&J expects guselkumab to be a strong driver of growth for the company. It plans to price TREMFYA competitively, compared to other biologic drugs on the market for the treatment of plaque psoriasis and to limit the out-of-pocket expense for patients with commercial insurance to $5 or less per dose.
