Business
FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis
FDA has set a target action date of July 29, 2022NDA supported by positive efficacy data from the pivotal Phase 3 DERMIS 1 and DERMIS 2 clinical studies, as
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"FDA has set a target action date of July 29, 2022NDA supported by positive efficacy data from the pivotal Phase 3 DERMIS 1 and DERMIS 2 clinical studies, as well as results from the long-term safety studyIf approved, roflumilast cream would be the first and only topical PDE4 inhibitor for psoriasis WESTLAKE VILLAGE, Calif., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration’s (FDA) acceptance for review of the company’s 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,” said Frank Watanabe, President and CEO of Arcutis. “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,” said Patrick Burnett, M.D., Ph.D., 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) we...