FDA pushes PDUFA date of tapinarof cream, 1% for atopic dermatitis to 2025
The federal agency has not raised any concerns regarding safety and efficacy of tapinarof cream, 1%.
FDA pushes PDUFA date of tapinarof cream, 1% for atopic dermatitis to 2025 | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.
The Prescription Drug User Fee Act (PDUFA) date for Dermavant's (now part of Organon) tapinarof cream, 1% (VTAMA) to treat atopic dermatitis in adults and children aged 2 years and up, has been extended by 3 months. The new target action date has been set for March 12, 2025, the global healthcare company announced in a press release.1,2
Organon stated the federal agency has not raised any concerns regarding the safety or efficacy of tapinarof cream, 1%, and have not raised any concerns regarding the approvability for the indicated patient population. The FDA requested final datasets and clinical study report from the long-term extension study for tapinarof cream, 1%. Upon receiving these datasets, the federal agency determined "that the additional information requested constitutes a major amendment to the sNDA resulting in a standard three-month extension to the original target action date," stated Organon.1
"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, 1%] for AD and we are committed to working with the FDA ensure the agency has all the information it needs for its review,” said Juan Camilo Arjona Ferreira, MD, head of Research & Development at Organon, in a statement.1
The FDA originally accepted tapinarof's supplemental New Drug Application on April 29, 2024, based on data from the ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) phase 3 trials supported the sNDA. The trials are identical, double-blind, randomized, and vehicle-controlled.3
In January 2024, Dermavant announced results from an integrated analysis spanning the ADORING development program, also including the on-going ADORING 3 open-label, long-term extension (LTE) study evaluating safety and efficacy of tapinarof cream, 1% in AD patients for up to 48 weeks.3
Overall, the integrated analysis revealed that 73% achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear), with at least a 2-grade improvement from baseline. Nearly 81% of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75).3
For patients aged 12 years and older, 77.9% with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or greater achieved a 4-point or greater reduction in PP-NRS.3
Topline data for the topical, steroid-free, aryl hydrocarbon receptor from the ADORING 3 LTE was presented at the 44th Annual Fall Clinical Dermatology Conference in October 2024.4
Of the 728 patients enrolled in the LTE, 83% were pediatric patients aged 2 to 17 years. In all, 51.9% of patients entered with or achieved complete disease clearance at least once during the 48-week study. In addition, 81.6% entered with or achieved clear or almost clear skin (vIGA-AD=0 or 1) at least once during the 48-week study, according to previous coverage by Contemporary Pediatrics.4
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. Organon. Press release. November 5, 2024. Accessed November 6, 2024. https://www.businesswire.com/news/home/20241105332994/en/Update-on-FDA-Review-of-VTAMA%C2%AE-tapinarof-Cream-1-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-2-Years-of-Age-and-Older
2. Organon Completes Acquisition of Dermavant, including Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%. Organon. October 28, 2024. Accessed November 6, 2024. https://www.organon.com/news/organon-completes-acquisition-of-dermavant-including-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/
3. Fitch, J. FDA accepts sNDA for tapinarof cream, 1% to treat AD in children 2 years and up. Contemporary Pediatrics. April 29, 2024. Accessed November 6, 2024. https://www.contemporarypediatrics.com/view/fda-accepts-snda-for-tapinarof-cream-1-to-treat-ad-in-children-2-years-and-up
4. Fitch, J. Fall Clinical: Long-term extension data of tapinarof cream 1% for atopic dermatitis. Contemporary Pediatrics. October 25, 2024. Accessed November 6, 2024. https://www.contemporarypediatrics.com/view/fall-clinical-long-term-extension-data-of-tapinarof-cream-1-for-atopic-dermatitis
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