FDA Extends Review of Tapinarof Cream for Pediatric Atopic Dermatitis
核心洞察
The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for tapinarof cream (搜索), 1% (VTAMA) for treating atopic dermatitis (搜索) in children aged 2 years and older to March 12, 2025.
The extension was prompted by the FDA's request for final datasets and a clinical study report from the long-term extension study of tapinarof cream (搜索), which the agency deemed a major amendment.
Organon, the manufacturer, remains confident in the efficacy and safety data supporting the review of tapinarof cream (搜索) for atopic dermatitis (搜索) and is committed to working with the FDA.
The FDA has extended the review period for tapinarof cream (搜索), 1% (VTAMA), a treatment developed by Dermavant (搜索) (now part of Organon) for atopic dermatitis (搜索) (AD) in adults and children aged 2 years and older. The new target action date under the Prescription Drug User Fee Act (PDUFA) is now set for March 12, 2025. This extension follows the FDA's request for additional data from the long-term extension study of the drug.
FDA Request for Additional Data
According to Organon, the FDA has not raised any concerns regarding the safety or efficacy of tapinarof cream (搜索), nor have they expressed concerns about its approvability for the intended patient population. The FDA's request specifically involves final datasets and the clinical study report from the long-term extension study. The agency classified this request as a major amendment to the supplemental New Drug Application (sNDA), leading to the standard three-month extension.
Juan Camilo Arjona Ferreira, MD, Head of Research & Development at Organon, stated, "Organon remains confident in the robust efficacy and safety data package that has been submitted to the agency to support the review of [tapinarof cream (搜索), 1%] for AD, and we are committed to working with the FDA to ensure the agency has all the information it needs for its review."
Clinical Data Supporting the Application
The sNDA for tapinarof cream (搜索) was initially accepted by the FDA on April 29, 2024. This acceptance was based on data derived from the ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) phase 3 trials, which were designed as identical, double-blind, randomized, and vehicle-controlled studies.
An integrated analysis of the ADORING development program, including the ADORING 3 open-label, long-term extension (LTE) study, which evaluated the safety and efficacy of tapinarof cream (搜索), 1% in AD patients for up to 48 weeks, revealed promising results. The analysis showed that 73% of patients achieved a Validated Investigator Global Assessment for Atopic Dermatitis (搜索) (vIGA-AD) score of 0 (clear) or 1 (almost clear), with at least a 2-grade improvement from baseline. Furthermore, nearly 81% of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75).
In patients aged 12 years and older with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or greater, 77.9% achieved a 4-point or greater reduction in PP-NRS.
Long-Term Extension Study Results
Topline data from the ADORING 3 LTE study, presented at the 44th Annual Fall Clinical Dermatology Conference in October 2024, highlighted the long-term efficacy and safety of tapinarof cream (搜索). Of the 728 patients enrolled in the LTE, 83% were pediatric patients aged 2 to 17 years. The study found that 51.9% of patients entered with or achieved complete disease clearance at least once during the 48-week study, and 81.6% entered with or achieved clear or almost clear skin (vIGA-AD=0 or 1) at least once during the study period.