Dermavant Sciences has submitted a Supplemental New Drug Application (sNDA) to the U.S. FDA for Vtama® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. VTAMA cream, 1% is currently FDA-approved for the topical treatment of plaque psoriasis in adults.
The sNDA submission is supported by positive Phase 3 data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled, pivotal trials, as well as data from an interim analysis of ADORING 3, a Phase 3, 48-week, open-label, long-term extension study. In the pivotal trials, Vtama cream demonstrated highly statistically significant improvement compared to in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8, the primary endpoint. Vtama cream also demonstrated highly statistically significant improvement in the proportion of patients with ≥75% improvement in the Eczema Area and Severity Index (EASI75) from baseline to Week 8 compared to patients on vehicle, a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population in whom the PP-NRS is validated, who received Vtama cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another key secondary endpoint.
There were no new safety or tolerability signals of concern in the study cohorts, including children 2 years of age and older. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events.
Vtama cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream. In 2022 it became the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years.