FDA Extends Review of Organon's VTAMA for Atopic Dermatitis
Key Insights
The FDA has extended the target action date for reviewing Organon's supplemental New Drug Application for VTAMA (tapinarof) cream, 1%, to March 12, 2025.
This extension pertains to the treatment of atopic dermatitis (search) in adults and children aged two years and older.
The FDA has not expressed concerns regarding the safety or efficacy of VTAMA, nor about the approvability of this indication.
Organon & Co. [OGN] announced that the U.S. Food and Drug Administration (FDA) has extended the target action date for its review of the supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1%, for the treatment of atopic dermatitis (search) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original date of December 12, 2024.
The FDA has not raised any concerns regarding the safety or efficacy of VTAMA, nor have they indicated any issues with the potential approval of this expanded indication. This extension provides the FDA with additional time to review the application.
VTAMA, a topical, non-steroidal cream, is currently approved for the treatment of plaque psoriasis (search) in adults. The sNDA seeks to expand the drug's label to include atopic dermatitis (search), a chronic inflammatory skin condition affecting millions of people, including young children. If approved, VTAMA would offer a novel treatment option for this patient population.
Tapinarof is a novel, non-steroidal, topical treatment that activates the aryl hydrocarbon receptor (search) (AhR), a transcription factor that regulates gene expression. Activation of AhR has been shown to reduce inflammation and improve skin barrier function, both of which are impaired in atopic dermatitis (search). The clinical development program supporting the sNDA included data from multiple Phase 3 studies demonstrating the efficacy and safety of tapinarof in atopic dermatitis patients.
Organon's acquisition of Dermavant Sciences Ltd. (search) brought VTAMA into its portfolio. The company remains optimistic about the potential for VTAMA to address the unmet needs of patients with atopic dermatitis (search). While the target action date has been extended, Organon anticipates a positive outcome from the FDA review process.