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Tapinarof Cream for Adult, Pediatric Eczema Under FDA Review
On April 29, 2024, The US Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application for tapinarof cream, 1%, for the topical treatment of atopic dermatitis in adults and children aged ≥ 2 years, according to an announcement by the manufacturer, Dermavant Sciences.
Tapinarof cream, 1% (VTAMA) is a steroid-free aryl hydrocarbon receptor agonist currently approved for the topical treatment of plaque psoriasis in adults in the United States. According to a press release from Dermavant, the development was supported by positive phase 3 data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled, pivotal trials, as well as an open-label maximal usage pharmacokinetics trial in children aged 2-17 years and the interim analysis results of ADORING 3, a phase 3, 48-week, open-label, extension trial.
The FDA's decision on approval is expected in the fourth quarter of 2024, according to Dermavant.
