FDA Approves Tapinarof 1% Cream for Adult, Pediatric Patients with Atopic Dermatitis

A new US Food and Drug Administration (FDA) approval has been announced by Organon for tapinarof (Vtama) cream 1% treatment of atopic dermatitis among patients aged 2 years and older.¹

The December 16 announcement took place ahead of tapinarof’s extended target action date (PDUFA) of March 12, 2025. The medication is an aryl hydrocarbon receptor agonist and its approval for atopic dermatitis, commonly known as eczema, will add to the armamentarium of 1 of the most widespread inflammatory skin conditions globally.

“[Tapinarof] cream approval in [atopic dermatitis] is important because it can be prescribed for children as young as 2 years old,” Adelaide A. Hebert, MD, professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program. “[Tapinarof] cream has the potential to bring much needed relief to a significant number of children suffering from this disease.”¹

The approval follows the positive findings of the ADORING clinical trial program, during which tapinarof cream 1% was evaluated in individuals as young as 2 years with moderate-to-severe eczema. The ADORING 3 trial specifically was an open-label, long-term extension study lasting 48 weeks which involved patients from previous ADORING trials and newly-enrolled children aged 2–17 years with mild-to-severe disease.

In total, there had been 728 participants who were evaluated from the ADORING studies, with subjects having been treated with the topical cream until their disease cleared completely or until the conclusion of the study. There were 378 patients who were shown to have achieved complete clearance of their atopic dermatitis and discontinued treatment, with the average first treatment-free interval lasting approximately 80 consecutive days.

Participants whose skin symptoms returned to mild or more severe levels, based on the Validated Investigator Global Assessment for AD (vIGA-AD) scale, were re-treated with the topical medication until their condition resolved again. Overall, the ADORING trial results indicated significant improvements versus those given a placebo in terms of the proportion of subjects with clear (0) or almost clear (1) skin and those with a minimum 2-grade improvement on the Validated Investigator Global Assessment for AD (vIGA-AD) scale by the 8-week mark.

The investigators found that in ADORING 1, 45.4% of those on tapinarof cream met the aforementioned criteria compared to 13.9% in the vehicle arm. In ADORING 2, the research team found that 46.4% of those given tapinarof achieved such successes compared to 18.0% (P <0.0001 in both studies).

The investigators in these trials also noted statistically significant differences for several secondary endpoints. These included a 75% or greater Eczema Area and Severity Index score improvement (EASI 75) as well as a ≥4-point reduction in participants' Peak Pruritus Numerical Rating Scale (PP-NRS) for those aged 12 years and older.

“...[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 [tapinarof] cream,” Hebert said in her statement.¹

The long-term safety profile of tapinarof cream was found by the investigators to be consistent with observations at the 8-week mark in earlier studies. When looking at common adverse reactions, which were observed in at least 1% of participants, the most frequently reported examples included upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremities, and abdominal discomfort.

References

1. ^{FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. 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/. Date accessed: December 16, 2024.}
2. ^{Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. November 5, 2024. https://www.organon.com/news/update-on-fda-review-of-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/. Date accessed: December 16, 2024.}