FDA Approves Organon's VTAMA For Treatment Of Atopic Dermatitis

Organon & Company

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(RTTNews) - Organon (OGN), Monday announced that the U.S. Food and Drug Administration (FDA) has approved Vtama (tapinarof) cream, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.

Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.

"With the FDA's approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected," said Kevin Ali, Organon's Chief Executive Officer. "Introducing this new first-in-class therapy for AD patients reaffirms Organon's commitment to addressing areas of high unmet need."