Breakthrough in Topical Therapy for Adults and Children

Organon, a global healthcare company dedicated to improving women’s health throughout their lives, has announced a significant development in the treatment of atopic dermatitis (AD). The U.S. Food and Drug Administration (FDA) has granted approval for VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for the topical treatment of AD in adults and children as young as 2 years old. This approval came earlier than the extended target action date of March 12, 2025.

Kevin Ali, Organon’s Chief Executive Officer, emphasized the importance of this approval, stating, “VTAMA cream now offers a therapy for AD patients that provides powerful skin clearance without label warnings, precautions, contraindications, or restrictions on usage duration or affected body surface area. This new first-in-class therapy reaffirms our commitment to addressing areas of high unmet need in healthcare.”

The ADORING pivotal studies demonstrated the efficacy of VTAMA cream, 1% in moderate to severe AD patients. The studies showed a statistically significant difference compared to the vehicle in achieving clear or almost clear skin with a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD). In ADORING 1, 45.4% of patients achieved this result versus 13.9% in the vehicle group, while in ADORING 2, the figures were 46.4% versus 18.0% (both P<0.0001).

Secondary endpoints, including improvements in the Eczema Area and Severity Index (EASI) score and the Peak Pruritus Numerical Rating Scale (PP-NRS), also showed statistically significant differences. The most common adverse reactions included upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

ADORING 3, a 48-week open-label, long-term extension study, enrolled 728 patients, including those from previous studies and new participants. This study assessed the long-term safety and efficacy of VTAMA cream, including the duration of treatment-free intervals. For patients who achieved complete disease clearance, the mean duration of the first treatment-free interval was approximately 80 consecutive days.

Dr. Adelaide A. Hebert, 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, highlighted the significance of VTAMA cream’s approval for children as young as 2 years old. She noted, “The itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with the use of VTAMA cream, which is crucial given the burden that itch places on patients and their families.”

It’s worth noting that VTAMA cream was previously approved by the FDA in May 2022 for the treatment of plaque psoriasis in adults, making it the first non-steroidal topical novel chemical entity launched for this condition in the U.S. in over 25 years.

Commentary by YourDailyFit columnist Alice Winters:

The FDA’s approval of VTAMA cream for atopic dermatitis represents a significant advancement in the treatment landscape for this chronic skin condition. As a topical therapy that can be used in both adults and children as young as 2 years old, VTAMA addresses a crucial need in dermatological care, especially considering the prevalence of AD in pediatric populations.

Several aspects of this approval are particularly noteworthy:

1. Novel Mechanism of Action: As an aryl hydrocarbon receptor agonist, VTAMA introduces a new class of topical treatment for AD. This innovative approach could potentially offer benefits to patients who have not responded well to existing therapies.

2. Safety Profile: The absence of label warnings, precautions, contraindications, and restrictions on usage duration or affected body surface area is remarkable. This favorable safety profile could make VTAMA an attractive option for long-term management of AD, particularly in children where safety concerns often limit treatment options.

3. Efficacy Data: The ADORING studies demonstrated significant improvements in skin clearance and itch reduction. The achievement of clear or almost clear skin in nearly half of the treated patients is impressive, especially considering the challenging nature of moderate to severe AD.

4. Long-term Management: The results from ADORING 3, showing an average treatment-free interval of 80 days, suggest that VTAMA may offer extended periods of relief between treatments. This could significantly improve quality of life for patients and reduce the burden of constant treatment application.

5. Dual Indication: The previous approval for plaque psoriasis adds to VTAMA’s versatility, potentially simplifying treatment regimens for patients with multiple skin conditions.

However, it’s important to consider some limitations and areas for further research:

1. Long-term Safety: While the 48-week extension study provides valuable data, continued monitoring will be crucial to establish the long-term safety profile, especially in pediatric patients.

2. Comparative Efficacy: Studies comparing VTAMA to other established AD treatments would be beneficial to guide clinical decision-making.

3. Cost and Accessibility: As a novel therapy, the cost of VTAMA and its accessibility to patients, particularly those in lower socioeconomic brackets, will be important factors in its real-world impact.

4. Mechanism of Action: Further research into the precise mechanisms by which VTAMA affects AD could lead to additional therapeutic applications or refinements.

In conclusion, the approval of VTAMA cream for atopic dermatitis represents a promising addition to the dermatological armamentarium. Its novel mechanism, favorable safety profile, and efficacy in both adult and pediatric populations position it as a potentially game-changing therapy in the management of AD. As with any new treatment, post-marketing surveillance and real-world evidence will be crucial in fully understanding its place in clinical practice. Nonetheless, VTAMA’s approval marks a significant step forward in addressing the unmet needs of patients with atopic dermatitis.