FDA Extends Review of Tapinarof Cream for Atopic Dermatitis, Citing Need for Additional Data
核心洞察
The FDA has extended the review period for tapinarof cream 1% for atopic dermatitis (搜索) by three months, with a new PDUFA date set for March 12, 2025.
The extension was prompted by the FDA's request for final datasets and the clinical study report from the Phase 3 ADORING 3 open-label extension trial.
Tapinarof demonstrated significant efficacy in the ADORING 3 trial, with 51.9% of participants achieving complete disease clearance over 48 weeks.
The FDA has extended the target action date for its review of the supplemental New Drug Application (sNDA) for tapinarof cream, 1%, in treating atopic dermatitis (搜索) (AD) in adults and children aged 2 years and older. The new Prescription Drug User Fee Act (PDUFA) action date is now March 12, 2025, moved from the original date of December 12, 2024.
The FDA's decision to extend the review period was influenced by the submission of additional data from the Phase 3 ADORING 3 open-label long-term extension trial. Organon, the sNDA sponsor, provided the final datasets and clinical study report from this trial at the FDA's request. The agency considered this new information a "major amendment" to the application, necessitating the standard three-month extension.
ADORING 3 Trial Efficacy
The ADORING 3 trial evaluated the long-term efficacy and safety of tapinarof cream 1% in participants with atopic dermatitis (搜索). Efficacy was assessed using the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, with endpoints including complete disease clearance (0) and clear (0) or almost clear (1) skin. After 48 weeks, 51.9% of participants achieved complete disease clearance at least once during the study period. Furthermore, 81.6% of participants achieved clear or almost clear skin at least once during the 48 weeks.
Juan Camilo Arjona Ferreira, MD, Head of Research and Development at Organon, stated the company's confidence in the efficacy and safety data submitted to the agency, affirming their commitment to providing the FDA with all necessary information for its review.
Tapinarof Background
Tapinarof is an aryl hydrocarbon receptor (搜索) agonist currently marketed as Vtama for the topical treatment of plaque psoriasis (搜索) in adults. The original sNDA submission for the atopic dermatitis (搜索) indication included data from the Phase 3 ADORING 1 and ADORING 2 clinical trials. These trials compared the efficacy and safety of tapinarof cream 1% to a vehicle control cream in adult and pediatric participants with atopic dermatitis.
ADORING 1 and 2 Trial Results
Both ADORING 1 and ADORING 2 demonstrated statistically significant improvements in vIGA-AD scores for patients treated with tapinarof cream compared to the vehicle control group. In ADORING 1, 45.4% of patients treated with tapinarof achieved vIGA-AD success compared to 13.9% in the vehicle control group (P < .001). Similarly, in ADORING 2, 46.4% of patients treated with tapinarof achieved vIGA-AD success compared to 18.0% in the vehicle control group (P < .001).