FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11

Expanded indication for ZORYVE provides new, steroid-free topical for children 6 to 11 with plaque psoriasis, including intertriginous psoriasis

WESTLAKE VILLAGE, Calif., Oct. 06, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) to expand the indication of ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years. ZORYVE, a once-daily, steroid-free cream that is effective, safe, and well tolerated, is designed to simplify management of plaque psoriasis.

“Young children with plaque psoriasis lack treatment options, which is why today’s decision by the FDA represents a meaningful advancement for this pediatric population, their parents, and caregivers,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “ZORYVE has been shown to be safe, well tolerated, and effective; all critical factors for treating children with plaque psoriasis. We are excited to now be able to expand the availability of ZORYVE to children as young as 6 years old, offering them and their families an important new steroid-free treatment option to consider along with their healthcare providers.”

As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 6 to 11 years of age, and presents with very similar clinical features, including “plaques,” or raised, red areas of skin covered with a silver or white layer of dead skin cells. Plaques in sensitive areas, where the skin may be thinner or more sensitive, pose specific treatment challenges.

“In children, psoriasis ranges from mild to severe, and more often appears on sensitive areas including the face and skin folds, compared to adults. Topical steroids are commonly recommended medications for the treatment of pediatric psoriasis. However, they come with safety and tolerability concerns related to long-term use. Steroid-free topical treatments that can be used on sensitive areas are especially needed for managing plaque psoriasis in younger children,” said Adelaide A. Hebert, MD, professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann. “In clinical studies with ZORYVE in the pediatric population, efficacy was consistent with the pivotal Phase 3 DERMIS-1 and DERMIS-2 trial results in adults. In addition, ZORYVE was shown to be safe and well tolerated, an important consideration for managing plaque psoriasis, especially in children.”