Arcutis: Promising Data From Lead Drug In Pediatric Atopic Dermatitis

 Arcutis Biotherapeutics Inc ARQT announced that the INTEGUMENT-PED Phase 3 trial of roflumilast cream 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis met its primary endpoint and all secondary endpoints. 

For the primary endpoint, 25.4% of children treated once daily with roflumilast cream achieved Investigator Global Assessment (IGA) Success compared to 10.7% of children treated with the vehicle at Week 4, with significant improvements seen as early as Week 1.

39.4% of children treated with roflumilast cream achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75), a key secondary endpoint.

Roflumilast cream was very well-tolerated. 

The Company recently announced the submission of a supplemental New Drug Application to the FDA for roflumilast cream 0.15% for mild to moderate atopic dermatitis in adults and children ages six years and older. 

Following the potential approval of roflumilast cream 0.15% and based on these results, Arcutis intends to submit an sNDA for roflumilast cream 0.05% for mild to moderate atopic dermatitis in children ages 2 to 5 years.

https://www.benzinga.com/general/biotech/23/09/34734553/arcutis-biotherapeutics-reveals-promising-data-from-lead-drug-in-pediatric-patients-with-atopic-d