The U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Dermavant’s tapinarof cream, 1% (VTAMA), for the treatment of atopic dermatitis (AD) in both adults and children aged 2 years and older. The new target action date is set for March 12, 2025, the global healthcare company, now part of Organon, announced in a press release.
The company clarified that the FDA has not raised any concerns regarding the safety, efficacy, or approvability of tapinarof cream for the indicated patient population. However, the agency requested additional data, specifically final datasets and a clinical study report from the ongoing long-term extension study for the drug. Upon receiving this supplementary information, the FDA determined that the new data constituted a major amendment to the supplemental New Drug Application (sNDA), prompting a three-month extension to the original PDUFA date.
“Organon remains confident in the robust efficacy and safety data package submitted to the FDA to support the review of tapinarof cream for atopic dermatitis,” said Dr. Juan Camilo Arjona Ferreira, Head of Research & Development at Organon. “We are committed to working with the FDA to ensure the agency has all the necessary information for its review.”
The FDA had previously accepted tapinarof’s sNDA on April 29, 2024, based on data from two pivotal phase 3 trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859). These identical, double-blind, randomized, vehicle-controlled trials provided key support for the sNDA.
In January 2024, Dermavant released results from an integrated analysis of the ADORING trials, which included data from the ongoing ADORING 3 open-label, long-term extension (LTE) study. The LTE study is evaluating the safety and efficacy of tapinarof cream in AD patients over a period of up to 48 weeks.
The integrated analysis showed promising results, with 73% of patients achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear), and a 2-grade improvement from baseline. Additionally, 81% of patients saw at least a 75% improvement in the Eczema Area and Severity Index (EASI75).
For patients aged 12 and older, 77.9% of those with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or higher achieved a 4-point or greater reduction in pruritus.
Topline data from the ADORING 3 LTE study, presented at the 44th Annual Fall Clinical Dermatology Conference in October 2024, revealed that of the 728 patients enrolled, 83% were pediatric patients aged 2 to 17 years. Of these, 51.9% achieved complete disease clearance at least once during the 48-week study, while 81.6% experienced clear or almost clear skin (vIGA-AD score of 0 or 1) at least once.
Dermavant’s tapinarof cream, a topical, steroid-free treatment targeting the aryl hydrocarbon receptor, is positioned to offer a new therapeutic option for individuals with atopic dermatitis, pending FDA approval in 2025.
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