On April 29, 2024, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application for Tapinarov Cream 1% for topical treatment. atopic dermatitis It is indicated for adults and children over 2 years of age, according to a statement from the manufacturer, Dermavant Sciences.
Tapinarov cream, 1% (VTAMA) is a steroid-free aryl hydrocarbon receptor agonist currently approved for topical treatment of plaque psoriasis In US adults.according to press release Development from Dermavant was supported by positive Phase 3 data from Dermavant. longing 1 and longing 2two identical double-blind randomized vehicle-controlled pivotal trials and open-label maximum-dose pharmacokinetic studies and interim analysis results in children 2 to 17 years of age. Adoring 3a phase 3, 48-week, open-label extension study.
An FDA approval decision is expected in the fourth quarter of 2024, Dermavant said.
