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Arcutis Biotherapeutics Announces Health Canada Accepts for Review the New Drug Submission for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis
Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as well as results from long-term safety
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as well as results from long-term safety studiesIf approved, roflumilast cream would be the first and only topical PDE4 inhibitor for psoriasis in Canada Target action date of April 30, 2023 Arcutis is in process of establishing Canadian operations WESTLAKE VILLAGE, Calif., July 11, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), today announced that Health Canada has accepted for review the New Drug Submission (NDS) for roflumilast cream 0.3% for the treatment of plaque psoriasis in adults and adolescents. 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. The target action date is April 30, 2023. “The acceptance for review of our NDS by Health Canada marks an important milestone not only for Arcutis but for the approximately one million Canadians living with plaque psoriasis who currently have limited options when it comes to topical treatments. Canadian dermatologists and their patients have played a critical role in our roflumilast clinical development program with one in four patients in our DERMIS trials enrolled in Canadian sites, so we look forward to providing topical roflumilast to them, if approved,” said Frank Watanabe, president and CEO of Arcutis. “Arcutis is establishing operations in Canada, and we have begun to build out a strong team with deep dermatology and commercialization experience to support the future approval and launch. We look forward to working closely with Health Canada during the review process.” Arcutis’ NDS submission is supported by positive data from Arcutis’ pivotal Phase 3 program and two long-term open label studies. 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%. Approximately 1 out of 4 (206/881) patients in DERMIS-1 and DERMIS-2 were enrolled in Canadian sites. Roflumilast met its primary endpoint and had an In...