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.

For More Such Health News, visit rttnews.com