Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.3% to treat plaque psoriasis in children as young as 2 years old. This approval expands the indication for the once-daily, steroid-free topical therapy, which is now suitable for use anywhere on the body with no restrictions on duration of use. The decision addresses a significant treatment gap for young children with a chronic, immune-mediated inflammatory skin disease. ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved for this patient population.

The FDA approval 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. The 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 came from an open-label extension study (ARQ-151-306), which evaluated the treatment for up to 24 weeks.

Frank Watanabe, president and chief executive officer of Arcutis, stated that the approval demonstrates the company's commitment to delivering meaningful innovation to the youngest children and their families. ZORYVE cream 0.3% is a potent and selective PDE4 inhibitor. This marks the seventh FDA approval for the ZORYVE portfolio in four years.

ZORYVE cream 0.3% was previously approved for the treatment of plaque psoriasis in adults and children down to age 6. The therapy is widely available via key wholesaler and dermatology pharmacy channels. Arcutis offers the ZORYVE Direct Program to help patients navigate insurance and reduce out-of-pocket costs, as well as the Arcutis Cares patient assistance program for eligible uninsured or underinsured patients.

Key Indications for ZORYVE