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FDA Accepts NDA for Roflumilast Cream


Arcutis has announced that the FDA has accepted the New Drug Application for roflumilast cream for adults and adolescent patients with plaque psoriasis.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022, for the New Drug Application (NDA) for roflumilast cream (ARQ-151; Arcutis Biotherapeutics) for the treatment of psoriasis in adults and adolescents.1

“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,” said Frank Watanabe, President and CEO of Arcutis, Westlake Village, California. “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 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, according to the release.

“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,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer, Arcutis Westlake Village, California. “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.”

This decision is supported by the DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) phase 3 pivotal studies in chronic plaque psoriasis. The studies were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center trials 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% compared to a vehicle rate of 6.1% (P<.0001), and 37.5% compared to a vehicle rate of 6.9% (P<.0001), in DERMIS 1 and DERMIS 2 respectively.

The treatment 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).

The action was also supported by the results from an open-label Phase 2b long-term safety study (NCT04286607). It showed the efficacy of roflumilast cream, and results were maintained through weeks 52 to 64. In all trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile, the release continued, with the most common adverse events (AEs) including diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).


1. FDA accepts Arcutis Biotherapeutics’ new drug application for roflumilast cream for adults and adolescents with plaque psoriasis. Arcutis Biotherapeutics. Published December 22, 2021. Accessed December 22, 2021. https://www.arcutis.com/fda-accepts-arcutis-biotherapeutics-new-drug-application-for-roflumilast-cream-for-adults-and-adolescents-with-plaque-psoriasis/

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