Dermavant Sciences has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VTAMA (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older.
“We are confident, that VTAMA cream, if approved by the FDA, will be well positioned as a safe, well-tolerated, steroid-free topical treatment option for patients 2 years of age and older with AD and could provide for long-term disease management, representing meaningful advancement for patients, caregivers, and healthcare providers.”
–Todd Zavodnick, Chief Executive Officer of Dermavant,
VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD.
VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation studied in the ADORING Phase 3 development program and included in the sNDA submission for atopic dermatitis.
The sNDA is supported by positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the Phase 3 ADORING 3 open-label, long-term extension trial.
In both ADORING 1 and ADORING 2, VTAMA cream demonstrated highly statistically significant improvement in the primary endpoint of validated Investigator Global Assessment for Atopic Dermatitis (vIGA- AD) success over vehicle at Week 8 and all key secondary endpoints were statistically significant.
“The prevalence of atopic dermatitis, an extremely burdensome skin condition, continues to grow, and there is an increasing need for new, long-term, treatment options, especially for children,” says Todd Zavodnick, Chief Executive Officer of Dermavant, in a news release. “Today’s submission of our sNDA marks a significant milestone as we work towards the approval of VTAMA cream for patients suffering from atopic dermatitis as well as the families and caregivers of these patients. We are confident, that VTAMA cream, if approved by the FDA, will be well positioned as a safe, well-tolerated, steroid-free topical treatment option for patients 2 years of age and older with AD and could provide for long-term disease management, representing meaningful advancement for patients, caregivers, and healthcare providers.”
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 vehicle in the 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 Peak Pruritus Numeric Rating Scale (PP-NRS) score is validated, who received VTAMA cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the PP-NRS score compared to patients on vehicle, another key secondary endpoint. VTAMA cream, 1% data indicated no new safety or tolerability signals of concern in this population 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.