FDA Approves Tapinarof Cream 1% for Treatment of Atopic Dermatitis in Adults, Children 2 Years and Older

The FDA announced today the regulatory approval of tapinarof (Vtama; Organon) cream, 1%, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients aged 2 and older, according to a news release.¹

Atopic dermatitis can cause discomfort in patients of many ages. | Image Credit: Ольга Тернавская | stock.adobe.com

In the ADORING clinical trials, tapinarof cream, 1%, led to a statistically significant difference in the proportion of patients with moderate-to-severe AD achieving a score of clear (0) or almost clear (1) in the resolution of their AD compared to those receiving vehicle treatment.¹

“Vtama cream approval in AD is important because it can be prescribed for children as young as 2 years old,” said Adelaide A Herbert, MD, lead investigator for the ADORING program, in the news release. “Vtama cream has the potential to bring much needed relief to a significant number of children suffering from this disease.”¹

Furthermore, a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD 45.4% vs 13.9% of patients in ADORING 1 and 46.4% vs 18.0% in ADORING 2 (both P < .0001). The investigators also reported a statistically significant difference between patients who received tapinarof cream and those that received vehicle in all secondary end points. Among those reported were improvements of at least 75% in Eczema Area and Severity Index score from baseline at week 8.¹

Common adverse reactions, with an incidence of 1% or greater, included upper respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area pain (1%), according to the investigators.¹

Pharmacokinetics of tapinarof were further investigated in the ADORING 3 open-label, long-term extension trial that enrolled 728 patients and included efficacy end points such as complete disease clearance and the presence of clear or almost clear skin. Patients that entered with or achieved complete disease clearance and proceeded to discontinue treatment with tapinarof had a mean duration of 80 consecutive days in the treatment-free interval.¹

Earlier this year, the FDA accepted a supplemental new drug application for tapinarof cream, 1%, based on the positive ADORING 1 and 2 trial results and interim data from ADORING 3. With a Prescription Drug User Fee Act date previously set for the fourth quarter of 2024, the approval puts the drug on track to be on pharmacy shelves in 2025.²

Tapinarof cream, 1%, previously received FDA approval in May 2022 for the treatment of plaque psoriasis in adults. It became the first non-steroidal novel chemical entity designed for psoriasis in the United States in over 25 years.²

As advancements continue down the clinical trial pipeline, it will be critical to ensure proper representation in dermatology studies. Experts have previously highlighted the need to increase diversity in dermatologic clinical trials to provide more comprehensive datasets and better detail on the effectiveness of dermatitis treatments in varying populations.³

“Our armamentarium has strengthened greatly, and we’ve been offered so much more for our patients of all skin types, especially our patients with skin of color, who have historically had so many unmet needs in terms of treatment options,” Andrew F. Alexis, MD, MPH, FAAD, said in a recent interview with Pharmacy Times.³

REFERENCES

1. Organon. FDA approves Vtama® (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News Release. Released 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/

2. Antrim A. FDA accepts supplemental new drug application for tapinarof cream, 1%, in atopic dermatitis. Pharmacy Times. Published April 29, 2024. Accessed December 16, 2024. https://www.pharmacytimes.com/view/fda-accepts-supplemental-new-drug-application-for-tapinarof-cream-1-in-atopic-dermatitis

3. Ferruggia K. Experts highlight the need for greater diversity in dermatological clinical research. Pharmacy Times. Published September 14, 2024. Accessed December 16, 2024. https://www.pharmacytimes.com/view/experts-highlight-the-need-for-greater-diversity-in-dermatological-clinical-research