The U.S. Food and Drug Administration (FDA) has approved Organon's Vtama (tapinarof) cream, 1%, for the topical treatment of atopic dermatitis (AD) in adults and pediatric patients aged 2 years and older. This approval, which came ahead of the PDUFA date of March 12, 2025, marks a significant advancement in the treatment of AD, commonly known as eczema, providing a novel, non-steroidal option for patients.
Vtama cream, an aryl hydrocarbon receptor agonist, demonstrated significant efficacy and safety in the ADORING clinical trial program. The studies included patients with moderate to severe AD, with notable improvements observed in skin clearance and itch reduction. The approval provides a new first-in-class therapy for AD patients, addressing a high unmet need, according to Organon's Chief Executive Officer, Kevin Ali.
Clinical Trial Data
The ADORING 1 and ADORING 2 trials, which were pivotal, double-blind, randomized, and vehicle-controlled, evaluated the efficacy and safety of Vtama cream 1% in patients aged 2 years and older with moderate to severe AD. Patients were randomized in a 2:1 ratio to receive either Vtama cream or a vehicle cream once daily for 8 weeks.
The primary endpoint was achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 8. Key secondary endpoints included the proportion of patients achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI75) and a ≥4-point improvement in the Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of age.
Results from ADORING 1 showed that 45.4% of patients treated with Vtama cream achieved the primary endpoint compared to 13.9% in the vehicle group (P < 0.0001). Similarly, in ADORING 2, 46.4% of patients in the Vtama group achieved the primary endpoint versus 18.0% in the vehicle group (P < 0.0001).
Statistically significant differences were also observed in the secondary endpoints, including EASI75 and PP-NRS scores, demonstrating the cream's effectiveness in reducing both the severity of eczema and the intensity of itch.
Long-Term Efficacy and Safety
ADORING 3, a 48-week open-label extension study, further evaluated the long-term safety and efficacy of Vtama cream. The study enrolled 728 patients, including those from ADORING 1 and ADORING 2, as well as new enrollees aged 2-17 years with mild, moderate, or severe AD. Patients were treated with Vtama cream until complete disease clearance was achieved or until the study's completion.
For the 378 patients who achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment, the mean duration of the first treatment-free interval was approximately 80 consecutive days. The safety profile with long-term use was consistent with that observed at Week 8 in the pivotal studies.
Expert Commentary
Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital, and a lead investigator for the ADORING program, highlighted the importance of this approval for young patients. "Vtama cream approval in AD is important because it can be prescribed for children as young as 2 years old," she stated. "Vtama cream has the potential to bring much needed relief to a significant number of children suffering from this disease."
Dr. Hebert also emphasized the impact of itch in AD and the benefits observed with Vtama cream. "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."
Adverse Reactions
The most common adverse reactions (incidence ≥1%) observed in the clinical trials for atopic dermatitis were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and stomach-area (abdominal) pain.
About Atopic Dermatitis
Atopic dermatitis is a chronic inflammatory skin disease affecting over 26 million people in the U.S. and up to 10% of adults worldwide. It is most prevalent in children, affecting up to 20% globally. The disease is characterized by itchy, red, swollen, and cracked skin, often located on the folds of the arms, back of the knees, hands, face, and neck. Itching is a particularly bothersome symptom, worsening at night and disturbing sleep, which can lead to fatigue and inattention, especially in children.
Previous Approvals
In May 2022, the FDA approved Vtama (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults, marking it as the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in over 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.
