Arcutis Reports Positive Results For Integument Study Of Roflumilast Cream 0.05% In AD In Children

(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT), Wednesday announced positive results from the INTEGUMENT-open label extension long-term study of once-daily roflumilast cream 0.05% in the treatment of mild to moderate Atopic Dermatitis or AD in children 2 to 5 years old.

The study demonstrated durable efficacy and favorable safety profile, the company noted.

After 56 weeks, INTEGUMENT-PED achieved 75% improvement from baseline in Eczema Area and Severity Index.

The Phase 3 trial of roflumilast cream 0.05% had demonstrated rapid efficacy within the first 4 weeks of treatment, and showed long-term durable efficacy and tolerability.

Arcutis intends to submit an sNDA to the FDA in the first quarter of 2025 for roflumilast cream 0.05% for the treatment of AD in individuals ages 2-5 years.