Tapinarof Cream Under Review for Atopic Dermatitis

The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for tapinarof cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older.

Tapinarof is an aryl hydrocarbon receptor agonist currently marketed under the brand name Vtama^® for the topical treatment of plaque psoriasis in adults.

The sNDA is supported by data from the phase 3 ADORING-1 and ADORING-2 trials (ClinicalTrials.gov Identifier: NCT05014568, NCT05032859, respectively), which included pediatric and adult patients with atopic dermatitis that was present for at least 6 months for individuals 6 years and older or 3 months for those 2 to 5 years of age. 

The primary endpoint for both studies was the proportion of patients who achieved a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline to week 8. In both trials, a significantly greater proportion of patients treated with tapinarof cream achieved vIGA-AD success compared with those who received vehicle.

“The FDA acceptance of our sNDA is an important milestone in our efforts to bring Vtama cream, as a potentially safe and well-tolerated nonsteroidal treatment option, to adults and children as young as 2 years old who suffer from atopic dermatitis,” said Todd Zavodnick, CEO of Dermavant. “Our commitment to patients is unwavering, and we remain highly focused on preparing for the commercial launch of Vtama cream, subject to FDA approval, for its second indication of atopic dermatitis.”

A regulatory decision is expected in the fourth quarter of 2024.