FDA approves tapinarof cream for topical treatment of atopic dermatitis

The US Food and Drug Administration (FDA) has approved Vtama (tapinarof) cream 1%, an aryl hydrocarbon receptor agonist, for the topical treatment of atopic dermatitis in adults and children aged 2 years and older.

Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.

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. “Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”

In the ADORING pivotal studies, VTAMA cream, 1% demonstrated, in moderate to severe patients as young as 2 years old with AD, a statistically significant difference versus 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% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2 (both P<0.0001). The difference between patients who received VTAMA cream and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 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. The most common adverse reactions (incidence ≥1%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%).

ADORING 3, a 48-week open-label, LTE study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were VTAMA cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria.

In ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with VTAMA cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with VTAMA cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated with VTAMA cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8.

“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,” said 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. “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.”

In May 2022, the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults, making it the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis with no label warnings or precautions, contraindications, restrictions on duration of use, or percentage of body surface area affected.

About Atopic Dermatitis

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom for those with AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.