Arcutis Biotherapeutics announced on February 26, 2025, that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%. This application is for the topical treatment of mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years old.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025, for this application. This acceptance is a crucial step towards potentially offering a new steroid-free treatment option for approximately 1.8 million children in this age group living with AD.
The sNDA is supported by positive results from the pivotal INTEGUMENT-PED Phase 3 trial, the INTEGUMENT-OLE long-term extension study, and a Phase 1 pharmacokinetic study. Clinical trials demonstrated significant positive results in treating AD in children aged 2 to 5, with a favorable safety and tolerability profile, which is important for long-term pediatric use.
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