FDA Approves Organon’s Vtama Cream, 1% for Atopic Dermatitis

Image Credit: Adobe Stock Images/meristock

The FDA has approved Organon’s Vtama (tapinarof) cream, 1%, for the treatment of atopic dermatitis (AD) in adults and children as young as two years of age. According to the company, the approval was granted ahead of its Prescription Drug User Fee Act target action date of March 12, 2025, marking a significant milestone as the treatment offers a steroid-free option with no label warnings, contraindications, or restrictions on treatment duration or body surface area affected.¹

“With the FDA’s approval of Vtama cream in atopic dermatitis for adults and children as young as two 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, CEO, Organon, in a press release. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”

Approval was based on results from the three pivotal ADORING trials.1 ADORING 1 and ADORING 2 were identical, double-blind, randomized, vehicle-controlled, pivotal Phase III trials. As part of the trials, patients were randomly assigned in a 2:1 ratio to receive Vtama or vehicle for eight weeks. The primary endpoint of the study was the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear and ≥2-grade improvement from baseline at week eight, with secondary endpoints including the proportion of patients who achieved ≥75% improvement in the Eczema Area and Severity Index (EASI75).²

ADORING 3 was a Phase III, 48-week open-label, long-term extension study, which enrolled eligible patients from ADORING 1, ADORING 2, a four-week maximal usage pharmacokinetics trial, and direct enrollees who were Vtama cream-naive aged 2-17 years with vIGA-AD scores of two, three, or four, respectively, and who did not meet inclusion criteria for the pivotal studies.

An assessment for vIGA-AD found that 45.4% of patients in the ADORING 1 study and 46.4% in the ADORING 2 study demonstrated a score of clear or almost clear, compared to 13.9% and 18% for the vehicle groups, respectively.

In ADORING 3, patients were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance and the achievement of clear or almost clear skin. As part of the trial, 378 patients who entered with or achieved complete disease clearance and then discontinued treatment demonstrated a mean duration of the first treatment-free interval of approximately 80 consecutive days.

Common adverse events included upper respiratory infections, folliculitis, headaches, asthma, vomiting, ear infection, extreme pain, and abdominal pain.¹

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

The FDA first approved Vtama in 2022 as a treatment for plaque psoriasis in adults, making it the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the United States in over 25 years.¹

References

1. FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Business Wire. December 16, 2024. Accessed December 17, 2024. https://www.businesswire.com/news/home/20241216414255/en

2. Dermavant Presents New Data on Treatment of Patients with Skin of Color from ADORING 1 and ADORING 2 Phase 3 Pivotal Trials of VTAMA® (tapinarof) Cream, 1% in Adults and Children 2 Years of Age and Older with Atopic Dermatitis at the 2024 American Academy of Dermatology Annual Meeting. Dermavant. March 8, 2024. Accessed December 17, 2024. https://dermavant.com/dermavant-presents-new-data-on-treatment-of-patients-with-skin-of-color-from-adoring-1-and-adoring-2/#:~:text=In%20ADORING%201%20(N=407,and%20Severity%20Index%20(EASI75).