Organon (OGN) said Monday that the US Food and Drug Administration has approved its Vtama cream, 1%, for an additional indication of topical treatment of atopic dermatitis in adults and children at least two years old.
The approval of the drug, also called tapinarof, followed pivotal studies in which up to 46% of patients treated with Vtama cream achieved treatment success on the Validated Investigator Global Assessment for AD at week 8, the company said.
Organon also said a 48-week long-term extension study showed that most of the patients achieved skin clearance at least once and did not need further treatment for about 80 consecutive days.
Vtama cream was approved in 2022 by the FDA for plaque psoriasis in adults.
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