
USFDAJun 29, 2026, 07:08 PM
Arcutis ZORYVE Cream FDA Approved for Plaque Psoriasis in Children 2+
AI Summary
Arcutis Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis to children down to age 2. ZORYVE cream 0.3% is a once-daily, steroid-free topical therapy that is safe, effective, and well-tolerated for use anywhere on the body with no limitations on duration of use. This approval addresses a significant treatment gap for young children with plaque psoriasis and represents the seventh FDA approval for ZORYVE in four years.
Key Highlights
- FDA approved ZORYVE cream 0.3% for plaque psoriasis in children as young as 2 years.
- ZORYVE cream is a once-daily, steroid-free topical treatment.
- It can be used anywhere on the body with no restrictions on duration of use.
- This marks the seventh FDA approval for ZORYVE in four years.
- Approval based on data from the 4-week MUSE study (ARQ-151-216) and long-term extension study (ARQ-151-306).
- Previously, ZORYVE cream was approved for adults and children down to age 6.
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