By Fineline Cube 
Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), the U.S. partner of Huadong Medicine Co., Ltd. (SHE: 000963), announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) Cream 0.05% as a topical treatment for mild to moderate atopic dermatitis (AD) in children aged 2‑5 years.
Key Highlights
| Item | Detail |
|---|---|
| Product | ZORYVE® (roflumilast) 0.05% cream |
| Indication | Mild‑to‑moderate AD in children 2‑5 yrs |
| Regulatory Status | FDA sNDA approval (U.S.) |
| Clinical Evidence | Phase 3 INTEGUMENT‑PED, long‑term INTEGUMENT‑OLE, Phase 1 PK |
| Safety Profile | Rapid clearance, excellent tolerability |
Clinical Development Summary
- Phase 3 INTEGUMENT‑PED – Demonstrated rapid clearance of AD lesions, with all primary and key secondary endpoints met.
- Long‑Term INTEGUMENT‑OLE – Confirmed sustained efficacy and safety over extended use.
- Phase 1 PK – Established a favorable pharmacokinetic profile in pediatric patients.
ZORYVE’s non‑steroidal PDE4 inhibition reduces inflammatory cytokine production, offering a steroid‑free alternative for young patients.
Strategic Collaboration with Huadong Medicine
- August 2023 – Huadong Medicine and Arcutis signed a collaboration to launch roflumilast in China.
- Phase 3 Results in China – 0.3% roflumilast cream (psoriasis) and 0.15% cream (AD) showed positive topline data.
- Upcoming Filings – Huadong plans NDA submissions for these indications in Q4 2025.
- Seborrheic Dermatitis – 0.3% roflumilast foam trial has FDA approval and is in active preparation.
About Arcutis Biotherapeutics
Arcutis Biotherapeutics is a U.S.‑based biopharmaceutical company focused on developing and commercializing innovative, non‑steroidal therapies for inflammatory skin diseases. The company’s pipeline includes next‑generation PDE4 inhibitors and topical anti‑inflammatory agents.
About Huadong Medicine
Huadong Medicine Co., Ltd. (000963.SZ) is a leading Chinese biopharma company specializing in the discovery, development, and commercialization of dermatology and immunology therapeutics. The partnership with Arcutis expands its portfolio of advanced topical treatments.-Fineline Info & Tech