FDA

Vtama cream now approved for atopic dermatitis

December 24, 2024

Brand name: Vtama

Generic name: tapinarof

Manufacturer: Organon

Approval date: December 16, 2024

FDA approved Vtama (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for the treatment of atopic dermatitis (AD) in adults and pediatric patients ≥2 years of age. Vtama had previously been approved for the treatment of plaque psoriasis in adults.

Efficacy

Efficacy was supported by data from two randomized trials: ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) involving 813 participants ages ≥2 years with AD who were randomized 2:1 to Vtama cream or vehicle applied once daily for 8 weeks. Vtama cream, 1% showed a statistically significant difference vs. vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD): 45.4% vs. 13.9% of participants in ADORING 1 and 46.4% vs. 18.0% in ADORING 2 (both P <0.0001). The difference between patients who received Vtama cream and those who received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of ≥75% (EASI75) from baseline at week 8 and achievement of a ≥4-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at week 8 in patients ≥12 years of age.

Safety

The most common adverse reactions (incidence ≥1%) in the ADORING trials were upper respiratory tract infection (12%), folliculitis (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and abdominal pain (1%).

Recommended dose

Vtama cream is applied as a thin layer to affected areas once daily.

Sources:

Organon. (2024, December 16). FDA Approves VTAMA (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. [Press release]. 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/

Organaon: Vtama (tapinarof). [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215272s002lbl.pdf