The approval of roflumilast 0.05% provides a steroid-free, once-daily treatment option for safe and effective long-term management of pediatric eczema.
Incyte announced the agency's decision, which was based on findings of significant reduction in atopic dermatitis signs and symptoms during the TRuE-AD3 clinical trial.
EADV 2025: Phase 3 ROCKET-SHUTTLE results showed the T-cell rebalancing therapy significantly improved AD signs and symptoms in treatment-experienced adults.
The novel IL-22 blocker was associated with improvements in EASI as early as week 1 for lower doses and week 2 for the highest dose, compared with placebo.