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Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis
Plaque psoriasis is a skin disease that affects approximately 8.6 million individuals in the U.S. and presents particular treatment challenges in certain
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Plaque psoriasis is a skin disease that affects approximately 8.6 million individuals in the U.S. and presents particular treatment challenges in certain anatomical regions.Roflumilast cream, a non-steroidal treatment intended for chronic use, would be the first and only topical PDE4 inhibitor for psoriasis, if approved.Roflumilast cream demonstrated statistically significant superiority over vehicle on the primary endpoint of IGA Success and statistically significant improvements in multiple secondary endpoints in pivotal Phase 3 studies.Roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile. WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis. 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. In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, would enable chronic use across the body, without many of the local tolerability issues associated with alternative treatments. “Today is a critical milestone for Arcutis in our efforts to bring innovative treatments to dermatologists and their patients, and is a reflection of our deep dermatology expertise,” said Frank Watanabe, President and CEO of Arcutis. “Individuals with plaque psoriasis currently do not have topical treatment options that offer a combination of good tolerability and the ability to be used for long periods of time, and that can be used on all parts of the body. If approved, roflumilast cream will be the first and only topical PDE4 inhibitor approved for psoriasis and an important non-steroidal treatment option for the millions of individuals struggling with plaque psoriasis. I want to thank the Arcutis team, as well as the clinical investigators, p...