FDA Approves Zoryve Cream for Plaque Psoriasis in Children as Young as 2 Years – Arcutis Biotherapeutics
Arcutis Biotherapeutics announced that the FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Zoryve (roflumilast) 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. 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.” – Lisa Swanson, MD, FAAD, board-certified pediatric dermatologist and clinical trial investigator, Ada West Dermatology.
“Parents and caregivers of young children with plaque psoriasis have faced a significant treatment gap for years, with very limited options, even though this skin condition can have a profound impact on the child and the entire family. The FDA approval of a once-daily, steroid-free topical treatment for children as young as 2 introduces an important new treatment option for a largely overlooked population and represents a significant advancement in pediatric psoriasis care.” – Leah Howard, president and chief executive officer, National Psoriasis Foundation.
Zoryve cream 0.3% was previously approved for the treatment of plaque psoriasis in adults and children down to age 6. The approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216) evaluating Zoryve cream 0.3% in children ages 2 to 5 years with plaque psoriasis. This open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy in children with plaque psoriasis involving at least 2% body surface area. Supportive long-term safety data were derived from an open-label extension study (ARQ-151-306), which evaluated the long-term safety, tolerability, and efficacy of Zoryve cream 0.3% in individuals ages 2 to 5 years with plaque psoriasis for up to 24 weeks of treatment. Results demonstrated safety and efficacy profiles that were generally consistent with those observed in the DERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adolescents and adults.
“Children with plaque psoriasis under age 6 have historically had few treatment options that are appropriate for long-term use, forcing families and clinicians to navigate care for a chronic, progressive skin condition with limited choices. Zoryve cream 0.3%, a potent and selective PDE4 inhibitor, directly addresses this treatment gap and is the first once-daily steroid-free treatment for plaque psoriasis approved down to age 2. This seventh FDA approval for Zoryve in four years demonstrates Arcutis’ commitment to delivering meaningful innovation to the youngest children and their families.” – Frank Watanabe, president and chief executive officer of Arcutis.
Zoryve cream is widely available today via key wholesaler and dermatology pharmacy channels. Arcutis is committed to ensuring predictable access across the Zoryve portfolio through a simplified copay and fulfillment process. The Zoryve Direct Program supports patients who have been prescribed Zoryve by helping navigate the insurance process, assisting with adherence, and providing access to the Zoryve Direct Savings Card Program to help reduce out-of-pocket costs for eligible commercially insured patients. The Company also offers the Arcutis Cares patient assistance program, which provides Zoryve at no cost to financially eligible patients who are uninsured or underinsured.
