The approval stems from clinical evaluations conducted on children under six, supplemented by safety data derived from an open-label extension study. This 0.3% cream formulation offers a new avenue for families managing a chronic, progressive skin condition that has historically lacked long-term treatment options suitable for early childhood.

Chief Executive Officer Frank Watanabe described the move as a significant milestone, noting that this marks the seventh FDA approval for the Zoryve platform in four years. By lowering the age threshold, Arcutis aims to alleviate the burden on clinicians and parents who previously faced restricted medical choices for pediatric plaque psoriasis.