Milestone Achievement: FDA Approves ZORYVE® Cream 0.05% for Ages 2–5
We’re proud to share that the U.S. Food and Drug Administration has approved ZORYVE® (roflumilast) cream 0.05% for the treatment of mild to moderate atopic dermatitis in children ages 2 to 5.
This is a major step forward for dermatologic care in very young children—and we’re honored to have played a central role by conducting the pivotal clinical trials for ZORYVE. In those trials, the treatment demonstrated rapid reductions in itch (as soon as 24 hours) and meaningful improvements in skin lesions, with a favorable safety profile consistent with earlier studies.
For caregivers and clinicians alike, this approval means a new, once‑daily, steroid‑free topical option that is safe for use across the body and suited for long‑term management.
We look forward to continuing our work supporting next‑generation dermatology treatments—bringing hope to patients and families navigating chronic skin disease.