Arcutis Biotherapeutics, Inc. an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration for the expanded indication of ZORYVE cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11. As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.
ZORYVE was approved by the FDA in July 2022 for the topical treatment of plaque psoriasis in adults and adolescents 12 years of age and older. ZORYVE is a steroid-free, topical PDE4 inhibitor which effectively clears plaque psoriasis in both hard-to-treat areas such as knees and elbows, as well as sensitive areas such as the face, intertriginous areas, and genitalia.
“Safety and tolerability are critically important in the treatment of children, and today young children lack treatment options for plaque psoriasis. This submission is an exciting step in our efforts to expand the availability of an effective, steroid-free treatment for children with plaque psoriasis,” said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. “ZORYVE is the first PDE4 approved for the treatment of psoriasis and, if approved by the FDA with the new data, dermatology clinicians will be able to treat patients down to 2 years of age.”
“ZORYVE demonstrated a favorable safety and tolerability profile in this pediatric population, with minimal local site reactions. ZORYVE, with our proprietary HydroARQ Technology™, is a non-greasy, moisturizing cream that spreads easily and is aesthetically pleasing to patients, and most importantly does not include sensitizing excipients or irritants such as propylene glycol,”
Frank Watanabe, President and CEO at Arcutis
The submission is based on data from two recently completed 4-week MUSE studies in children aged 2 to 11 years with plaque psoriasis. Pharmacokinetic, safety, tolerability, and efficacy data from these two studies are consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials. Arcutis worked with the FDA on the design of the MUSE studies, which are intended to fulfill FDA post-marketing requirements for ZORYVE.
About ZORYVE®
ZORYVE cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
About Arcutis
Arcutis Biotherapeutics, Inc. is an early commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata.