Organon (OGN) announced on Monday that the U.S. Food and Drug Administration (FDA) has granted approval for Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist, as an additional treatment option for atopic dermatitis (AD) in both adults and children aged 2 years and older. This approval was secured before the expected target action date of March 12, 2025 (PDUFA).
Kevin Ali, Chief Executive Officer of Organon, expressed, "With the FDA's green light for VTAMA cream in treating atopic dermatitis in both adults and children as young as 2 years, we now have a therapeutic option that promises effective skin clearance without any label warnings, precautions, contraindications, or restrictions on usage duration or the body surface area affected. Introducing this pioneering therapy underscores Organon's commitment to addressing significant unmet medical needs."
