The U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, for the treatment of mild, moderate, or severe atopic dermatitis (AD) in adults and children aged 2 years and older. This approval expands the use of VTAMA, previously approved for plaque psoriasis, to a broader patient population suffering from this chronic inflammatory skin condition sometime also known as eczema. VTAMA is an aryl hydrocarbon receptor (AHR) agonist that works by modulating skin and immune cell pathways involved in inflammation.
The approval was based on positive results from the phase 3 ADORING clinical trials, which showed that up to 46% of patients treated with VTAMA cream achieved clear or almost clear skin (vIGA-AD score of 0 or 1) after 8 weeks, compared to 18% of those using a placebo cream. Patients also experienced rapid itch relief, often within 24 hours of the first application, and many maintained skin clearance for an average of about 80 days without treatment, indicating a remittive effect. VTAMA cream demonstrated a favorable safety and tolerability profile, with no label warnings, contraindications, or restrictions on treatment duration or body surface area affected.
This new treatment option addresses a significant unmet need in managing atopic dermatitis, especially in children and adults seeking effective and safe topical therapies. Add to follow-up
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