FDA Accepts Arcutis Biotherapeutics’ NDA for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis


The FDA accepted Arcutis Biotherapeutics’ new drug application (NDA) for roflumilast cream for the treatment of psoriasis in adults and adolescents. The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022.

“With the FDA commencing a review of our NDA filing, we move one step closer to potentially providing a new topical treatment to the millions of Americans living with plaque psoriasis who have limited options beyond steroidal treatments,” says Frank Watanabe, President and CEO of Arcutis, in a news release. “We are proud to be addressing some of the most persistent medical challenges for individuals with serious skin disease and have assembled a strong team that is preparing to commercialize our first product, roflumilast cream, once approved. We look forward to working closely with the FDA during the review process.”

Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. PDE4 is an established target in dermatology.

“Topical treatments are the standard therapies for the majority of psoriasis patients, but they often come with compromises between efficacy, tolerability and long-term use,” says Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer, Arcutis. “With these challenges in mind, we developed roflumilast cream as a formulation for chronic use anywhere on the body, including the face and sensitive intertriginous areas.”

Arcutis’ NDA submission is supported by positive data from Arcutis’ pivotal Phase 3 program and a long-term Phase 2b open label study. DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS” One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy of roflumilast cream 0.3%. Roflumilast met its primary endpoint and had an Investigator Global Assessment (IGA) success rate of 42.4 percent compared to a vehicle rate of 6.1 percent (P<0.0001), and 37.5 percent compared to a vehicle rate of 6.9 percent (P<0.0001), in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvement over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). In the open-label Phase 2b long-term safety study, durable efficacy of roflumilast cream was observed and the treatment effect was maintained through 52 to 64 weeks. In all trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile. The most common adverse reactions include diarrhea, headache, insomnia, nausea, upper respiratory tract infection, and urinary tract infection.

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