Dermavant Sciences has submitted a supplemental new drug application to the FDA for VTMA (tapinarof) cream 1%, a treatment for atopic dermatitis (AD) in patients aged 2 years and older. VTMA cream, an aryl hydrocarbon receptor agonist, is already approved for treating adults with plaque psoriasis. This application is significant due to the growing prevalence of atopic dermatitis, particularly among children, and the need for new, long-term treatment options.

The submission for the new application is supported by results from the phase 3 ADORING 1 and 2 trials, and interim data from ADORING 3, showing approximately 80% of the participants were pediatric patients under 18 years. The findings indicated statistically significant improvements in Validated Investigator Global Assessment for Atopic Dermatitis scores and Eczema Area and Severity Index scores at week 8 compared with a control vehicle. Additionally, patients aged 12 years and older also experienced significant improvements in itch relief. Trial results demonstrated the treatment was well-tolerated, making it a promising option for both acute and long-term management of atopic dermatitis.

Reference: Dowd K. Dermavant submits new drug application for tapinarof cream in atopic dermatitis. Healio. Published February 15, 2024. Accessed February 23, 2024. https://www.healio.com/news/allergy-asthma/20240215/dermavant-submits-new-drug-application-for-tapinarof-cream-in-atopic-dermatitis