Organon announced on December 16, 2024, that the U.S. Food and Drug Administration (FDA) approved VTAMA (tapinarof) cream, 1%, for the topical treatment of atopic dermatitis (AD) in adults and pediatric patients two years of age and older. This approval was received prior to its extended target action date of March 12, 2025.
VTAMA cream is an aryl hydrocarbon receptor agonist and is a first-in-class therapy for AD patients. The approval provides a new treatment option with no label warnings or precautions, contraindications, or restrictions on duration of use or percentage of body surface area affected.
In the ADORING pivotal studies, VTAMA cream demonstrated a statistically significant difference versus vehicle in achieving clear or almost clear skin with a minimum 2-grade improvement from baseline at Week 8. This approval significantly expands the market for VTAMA, which was previously approved for plaque psoriasis in adults.
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