Arcutis Biotherapeutics announces FDA accepted its sNDA for ZORYVE foam

Arcutis Biotherapeutics announced the FDA has accepted its sNDA for ZORYVE foam 0.3%, a once-daily, next generation phosphodiesterase-4 inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned the application a PDUFA target action date of May 22, 2025. “ZORYVE foam, if approved, would represent a truly meaningful innovation for millions of people with scalp and body psoriasis whose symptoms have not been adequately addressed by existing treatments,” said Frank Watanabe, president and chief executive officer of Arcutis. “We look forward to working closely with the FDA during the review process for our fifth topical roflumilast regulatory submission in the United States in less than three years. This filing acceptance is a critical milestone in our mission to deliver new treatment options that address the urgent needs of individuals living with immune-mediated diseases and conditions.”