Arcutis Receives FDA Approval to Expand ZORYVE Indication to Children Aged 2
Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration has approved the supplemental New Drug Application to expand the indication for ZORYVE cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. ZORYVE cream 0.3% is a once-daily, steroid-free topical that is safe, effective, and well tolerated, and is suitable for use anywhere on the body with no limitations on duration of use. Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease that can begin early in life and persist for decades. Plaque psoriasis can appear as raised, red, or discolored areas of skin covered with silvery scales. "Young children with plaque psoriasis face unique challenges, including disease involvement on sensitive skin, such as the face and skin folds. Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use," said Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator, Ada West Dermatology. "In clinical studies, ZORYVE cream 0.3% demonstrated consistent safety and efficacy in improving the signs and symptoms of plaque psoriasis as seen in adults and adolescents, and was safe and well tolerated in children as young as age 2. This approval provides physicians and caregivers a targeted topical therapy that can be used anywhere on the body for any duration of time."
