FDA Approves Tapinarof Cream, 1% for Atopic Dermatitis in Patients 2 Years and Older

The US Food and Drug Administration (FDA) announced today that it has approved tapinarof cream, 1% (Vtama; Organon) for patients aged 2 years and older with atopic dermatitis (AD).¹ The approval is supported by positive data stemming from the phase 3 ADORING 1 and 2 studies, a pharmacokinetics trial in children, and interim results from the ongoing ADORING 3 trial.

“With the FDA’s approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,” said Kevin Ali, Organon’s Chief Executive Officer, in a statement. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”¹

In the ADORING studies, patients saw an improved Validated Investigator Global Assessment for AD score of clear (0) or almost clear (1) from baseline at week 8. In ADORING 1, 45.4% of patients achieved this while 46.4% reached this outcome in ADORING 2, versus 18% of patients on vehicle (p < 0.0001). Participants who received tapinarof cream compared to those who received vehicle saw at least a 75% improvement in Eczema Area and Severity Index score and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale. Itch relief was rapid, with patients and caregivers reporting improvement as early as 24 hours after the first application.

The aryl hydrocarbon receptor agonist was well-tolerated with ≥1% incidence of adverse events. The most commonly reported adverse effects were upper and lower respiratory tract infection, folliculitis, headache, asthma, vomiting, ear infection, pain in extremities, and abdominal pain.

The approval also was supported by data from ADORING 3, a 48-week open-label, long-term extension study. This trial included 728 eligible participants from ADORING 1, ADORING 2, a 4-week pharmacokinetics trial, and direct enrollees who were naive to tapinarof. 378 patients achieved complete disease clearance and discontinued treatment, with a mean duration of the first treatment-free interval of about 80 consecutive days. Patients whose AD returned were retreated until clearance was achieved. The long-term safety profile was consistent with the safety profile observed at week 8, even on affected sensitive skin areas.

In a press release, 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, said, “VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease. Moreover, 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."¹

Dermavant Sciences announced its supplemental New Drug Application (sNDA) submission for this drug and indication in April.² However, in November, the FDA announced it had extended the target action date for the sNDA for tapinarof cream, 1% by 3 months, shifting the Prescription Drug User Fee Act date to March 12, 2025.³ The extension stemmed from the FDA’s request for additional long-term study data but did not reflect concerns about the drug’s safety or efficacy.

References

1. FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. News release.BusinessWire. 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. Dermavant announces FDA acceptance of supplemental new drug application (sNDA) for Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. Dermavant Sciences. April 29, 2024. Accessed December 13, 2024. https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/

3. 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. News release. BusinessWire. November 5, 2024. Accessed December 13, 2024. https://www.businesswire.com/news/home/20241105332994/en/Update-on-FDA-Review-of-VTAMA%C2%AE-tapinarof-Cream-1-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-2-Years-of-Age-and-Older