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

October 6, 2023
FDA Approves Arcutis ZORYVE roflumilast Cream 03 for Treatment of Psoriasis in Children Ages 6 to 11 image

The expanded indication for ZORYVE provides a new, steroid-free topical for children 6 to 11 with plaque psoriasis, including intertriginous psoriasis.

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. 

“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,” says Adelaide A. Hebert, MD, professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann, in a news release. “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.”

The approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children ages 6 to 11 years with plaque psoriasis. Pharmacokinetic, safety, tolerability, and efficacy data from this study were generally consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adults. Results from a second MUSE study, in children ages 2 to 5 years, as well as data from an ongoing open label extension study to assess the long-term safety of roflumilast cream 0.3% in individuals with plaque psoriasis 2 years of age and older (ARQ-151-306), will be the subject of a future FDA review.

“Psoriasis is the second most common inflammatory skin disease in children, and it can significantly affect the quality of life of the child, their family members, and caregivers,” says Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation. “We are told by the experts that advise us that there are numerous challenges when it comes to treating children, and finding the right treatment regimen can be difficult, which is why we are encouraged by the advancements being made to alleviate the burden of disease for this population.”

“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,” adds 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.”

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