FDA Pushes Back PDUFA Date 3 Months for Tapinarof, 1% Cream for Atopic Dermatitis in Adults and Children

The US FDA today announced it has extended by 3 months the target action date of its review for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the treatment of atopic dermatitis (AD) in adults and children aged 2 years and older. According to sNDA sponsor Organon, the new prescription drug user fee act (PDUFA) action date is March 12, 2025, moved back from December 12, 2024.¹

The agency has not raised concerns about the safety or efficacy of tapinarof cream, 1% or about the approvability of the indication, according to Organon. Rather, during its sNDA review, the FDA asked Organon for the final datasets and clinical study report for the phase 3 ADORING 3 open label long-term extension trial findings announced in late October at the 2024 Fall Clinical Dermatology Conference.²

Efficacy endpoints in the open label trial included a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of complete disease clearance (0) and of clear (0) or almost clear (1) skin. After 48 weeks, ADORING 3 researchers reported that 51.9% of participants treated with tapinarof, 1% cream entered with complete disease clearance or reached that status at least once during the 48-week period. The proportion that entered with or achieved clear or almost clear skin at least once reached 81.6%.²

The FDA considered the new information a “major amendment” to the application that would require the agency’s standard 3-month extension to the original target date, Organon reported.¹

Tapinarof is an aryl hydrocarbon receptor agonist currently marketed under the brand name Vtama for the topical treatment of plaque psoriasis in adults.¹ The original sNDA submission for the atopic dermatitis indication included data from the identical phase 3 ADORING 1 and ADORING 2 phase 3 clinical trials which evaluated the efficacy and safety of tapinarof cream, 1% compared with vehicle control cream in adult and pediatric participants with AD.³

Findings from both trials showed a statistically significantly greater percentage of patients treated with tapinarof cream achieved vIGA-AD success compared with those who received the vehicle control cream. For ADORING 1, 45.4% vs 13.9%, respectively (P <.001) and ADORING 2, 46.4% vs 18.0%, respectively (P <.001).³

“Organon remains confident in the robust efficacy and safety data package that has been submitted to the Agency to support the review of Vtama for AD and we are committed to working with the FDA ensure the agency has all the information it needs for its review,” Juan Camilo Arjona Ferreira, MD, Organon head of research and development, said in the company news release.¹

References

1. 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. Organon. November 5, 2024. Accessed November 5, 2024. https://www.organon.com/news/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/

2. Halsey G. Atopic Dermatitis: Final ADORING 3 Open-Label Extension Trial Findings with Tapinarof Cream, 1% Announced. Patient Care. October 31, 2024. https://www.patientcareonline.com/view/atopic-dermatitis-final-adoring-3-open-lael-extension-trial-findings-with-tapinarof-1-announced

3. Halsey G. Dermavant: FDA Accepts sNDA for Tapinarof Cream 1% for Treatment of Adults, Children with Atopic Dermatitis. Patient Care. April 29, 2024. https://www.patientcareonline.com/view/dermavant-fda-accepts-snda-for-tapinarof-cream-1-for-treatment-of-adults-children-with-atopic-dermatitis