Arcutis Biotherapeutics submits sNDA for ZORYVE cream to FDA

Arcutis Biotherapeutics (ARQT) announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for ZORYVE cream 0.05%, a once-daily, next generation phosphodiesterase 4 inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The sNDA is supported by positive results from one pivotal Phase 3 trial, one pivotal long-term extension study, as well as a Phase 1 pharmacokinetic study. The INTEGUMENT-PED vehicle-controlled, pivotal Phase 3 trial enrolled 652 children 2 to 5 years of age, with a mean AD Body Surface Area of 22% overall, and ranging from 3% to 82%. In the study, at Week 4, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle, with significant improvements seen as early as Week 1. All secondary endpoints were also met, with significant improvements seen across all time points, including vIGA-AD success and vIGA-AD of ‘Clear’ and ‘Almost Clear’ at Week 1. In addition, 35.3% of children treated with roflumilast cream who had a baseline Worst Itch Numeric Scale score greater than or equal to4 achieved a four-point reduction in WI-NRS at Week 4. Roflumilast cream 0.05% was well-tolerated. Overall, the safety profile observed in 2- to 5-year-old pediatric subjects treated with ZORYVE cream 0.05% during the trial was consistent with the favorable safety profile established in adults and older pediatric subjects treated with ZORYVE cream 0.15% with mild to moderate AD. The most frequent adverse events occurring in the roflumilast arm greater than vehicle included upper respiratory tract infection, diarrhea, and vomiting. The submission is also supported by data from the INTEGUMENT-OLE open-label extension study in which patients ages 2 to 5 were treated for up to 52 weeks.