Organon (OGN) announced that the U.S. Food and Drug Administration or FDA has approved VTAMA or tapinarof cream, 1%, 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. “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.” … “Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream.”
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