FDA Accepts Arcutis sNDA for Roflumilast Cream in Atopic Dermatitis; Non-Steroidal Topical for Ages 6+
The FDA accepted Arcutis Biotherapeutics' supplemental new drug application (sNDA) for roflumilast cream 0.15% for atopic dermatitis treatment in adults and children ages 6+. Roflumilast is a non-steroidal phosphodiesterase-4 (PDE4) inhibitor already approved for psoriasis, now seeking expanded indication for eczema. The sNDA acceptance triggers a formal review timeline. Separately, Turn Therapeutics secured $25M from Avenue Capital to advance GX-03, a first-in-class non-systemic topical for moderate-to-severe AD, with Phase 2 RCT readout expected mid-2026.