Arcutis Says Health Canada Accepts For Review Roflumilast Cream NDS For Plaque Psoriasis
(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT) announced Monday 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. The target action date is April 30, 2023.
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.
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 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%.
A new drug application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adolescents and adults is also under review by the U.S. Food & Drug Administration (FDA). The FDA has set a target action date of July 29, 2022.
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