FDA Approves Tapinarof Cream 1% for Atopic Dermatitis in Adults and Children

The US Food and Drug Administration (FDA) has approved Organon’s VTAMA (tapinarof) cream, 1%, for the treatment of atopic dermatitis (AD) in adults and children as young as 2 years old. This new indication offers a first-in-class, steroid-free topical therapy with no label warnings, restrictions on duration of use, or body surface area limitations, addressing a critical unmet need for AD patients.

Tapinarof cream’s approval was supported by pivotal Phase III ADORING 1 and ADORING 2 studies, which demonstrated statistically significant improvements in skin clearance and itch relief. At week 8, up to 46% of patients treated with tapinarof achieved treatment success, defined as clear (0) or almost-clear (1) skin and a minimum 2-grade improvement in the validated investigator global assessment for AD (vIGA-AD), compared to 18% on vehicle (P < 0.0001). Additionally, patients experienced significant reductions in itch as early as 24 hours after the first application, a critical outcome for the highly burdensome condition.

In the 48-week open-label ADORING 3 long-term extension study, patients demonstrated sustained disease control. Those achieving complete clearance (vIGA-AD=0) remained treatment-free for an average of 80 consecutive days, highlighting tapinarof’s remittive effect. Across all studies, tapinarof exhibited a favorable safety profile, making it suitable for use on sensitive skin areas.

“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,” said Adelaide A. Hebert, MD, lead investigator for the ADORING program.

Atopic dermatitis, a chronic inflammatory skin disease affecting approximately 7% of the US population, is characterized by intense itch and recurrent skin lesions. Despite existing therapies, many patients, particularly children, experience suboptimal outcomes. Tapinarof cream’s unique mechanism of action as an aryl hydrocarbon receptor agonist provides a novel approach to treatment, offering new hope to patients seeking relief from this burdensome condition.

Reference

FDA approves VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. Oragnon. December 16, 2024. Accessed December 16, 2024. https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/