Positive Phase III trial of Dermavant's Vtama in atopic dermatitis
Dermavant Sciences, an immuno-dermatology-focused subsidiary of Switzerland-based Roivant Sciences (Nasdaq: ROIV), today announced positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase III studies to evaluate the efficacy and safety of topical Vtama (tapinarof) cream, 1% in adults and pediatric subjects down to two years old with moderate to severe atopic dermatitis (AD).
Since May 2022, Vtama cream has been approved in the USA for the topical treatment of plaque psoriasis in adults. Dermavant said it anticipates filing a supplemental New Drug Administration (sNDA) for Vtama in atopic dermatitis with the US Food and Drug Administration (FDA) in first-quarter 2024, with the hope of reaching the market in this indication in the second half of 2024.
Dermavant acquired rights to tapinarof from UK pharma major GSK (LSE: GSK) in 2018, under a deal valued at around $330 million.
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