Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) shares gained 1.5% in premarket trading Monday after the U.S. Food and Drug Administration (FDA) approved the company’s ZORYVE (roflumilast) cream 0.05% for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years.
The FDA’s approval of the supplemental new drug application (sNDA) gives parents and physicians a non-steroidal treatment option that can be used continuously and safely for young children with eczema. In clinical studies, the once-daily topical cream delivered rapid symptom improvement, with around 40% of children achieving a 75% reduction in symptoms within four weeks of treatment.
This marks the sixth FDA approval for the ZORYVE franchise in just over three years, further strengthening Arcutis’ position in dermatology. The company expects the new therapy to be widely available through major wholesalers and pharmacies by the end of October 2025.
“ZORYVE cream was intentionally formulated to address the critical unmet need in atopic dermatitis care, and it provides a safe, effective alternative to steroid treatments, targeting the underlying inflammation that drives disease activity,” said Frank Watanabe, President and CEO of Arcutis.
The approval was supported by data from the INTEGUMENT-PED Phase 3 trial, which showed that 25.4% of children treated with ZORYVE achieved treatment success, compared to 10.7% in the vehicle control group. Additionally, more than one-third of participants reported meaningful itch relief within four weeks.
Atopic dermatitis, one of the most common chronic skin conditions in children, affects approximately 1.8 million U.S. children aged 2 to 5 who receive topical treatments. The condition can disrupt sleep, cause emotional distress, and lead to social isolation, significantly affecting quality of life for both children and their families.
The most common side effects observed in trials included upper respiratory infections, diarrhea, vomiting, rhinitis, conjunctivitis, and headache.
Arcutis Biotherapeutics stock price
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