Tapinarof Cream Under FDA Review for Atopic Dermatitis Indication.

Dermavant Sciences has submitted a supplemental New Drug Application (sNDA) to the FDA for tapinarof cream, 1%, to treat atopic dermatitis (AD) in adults and children aged 2 and older. Tapinarof cream is already approved for treating plaque psoriasis in adults. The sNDA is based on positive data from phase 3 trials, which showed statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success. The most common adverse reactions to tapinarof cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus. [Extracted from the article]