- ZORYVE cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trials
- Roflumilast cream was well tolerated and demonstrated a favorable safety and tolerability profile for up to 56 weeks of treatment
- Approximately 1.8 million children with atopic dermatitis (AD) aged 2 to 5 are topically treated in the United States
WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase 4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old.
“When choosing a therapy for very young children living with AD, healthcare providers and caregivers have to account for unique considerations for pediatric patients, including sensitive skin, and select a medication that is appropriate for long-term use by a child with a chronic skin condition. Data from the pivotal trial demonstrated that roflumilast cream 0.05% provided consistent and rapid relief, and was well-tolerated,” said Rocco Serrao, MD, FAAD, of DOCS Dermatology and INTEGUMENT-PED and INTEGUMENT-OLE investigator. “If approved, roflumilast cream 0.05% would offer a new topical option with the potential to advance the standard of care for these young patients, offering fast relief to the children and their families from the onerous symptoms of AD.”
AD is a chronic, genetically predisposed, relapsing inflammatory skin disease that presents across the lifespan. The disease may appear as a red, intensely itchy rash that can occur anywhere on the body and may present differently in children and adults. Pediatric AD can negatively impact the quality of life of the child as well as their family or caregivers.
“Parents, caregivers, and healthcare professionals need to feel confident in their treatment plan. Our clinical development program for ZORYVE reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream, which was designed to deliver drug without disrupting the skin barrier or using sensitizing excipients and irritants. This lower concentration of roflumilast cream was intentionally formulated for the needs of younger children with AD and demonstrates our commitment to serving this vulnerable patient population,” said Frank Watanabe, president and CEO of Arcutis. “We look forward to the opportunity to offer ZORYVE cream 0.05%, if approved, as a new topical therapy for the 1.8 million children between the ages of 2 to 5 with AD and their families.”
The sNDA is supported by positive results from one pivotal Phase 3 trial, one pivotal long-term extension study, as well as a Phase 1 pharmacokinetic study. The INTEGUMENT-PED vehicle-controlled, pivotal Phase 3 trial enrolled 652 children 2 to 5 years of age, with a mean AD Body Surface Area (BSA) of 22% overall, and ranging from 3% to 82%. In the study, at Week 4, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle (P