Japan has approved tapinarof cream, 1% (Vtama, Dermavant) for the treatment of adults with psoriasis and patients 12 years of age and older with atopic dermatitis.
VTAMA cream, 1% is a novel, aryl hydrocarbon receptor agonist in development in the U.S. as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD). Dermavant recently filed a Supplemental New Drug Application (sNDA) in the U.S for the treatment of atopic dermatitis in adults and children two years of age and older, with a PDUFA date in Q4 2024. It is currently approved for the topical treatment of plaque psoriasis in adults in the U.S.
“I believe Japan Tobacco’s approval speaks to tapinarof’s unique proposition in Japan as a once-daily, cosmetically elegant and steroid-free, topical cream for both acute treatment and long-term management of psoriasis and atopic dermatitis and we applaud our partner’s success,” says Todd Zavodnick, Chief Executive Officer of Dermavant, in a news release. “Our commitment to bringing VTAMA (tapinarof) cream, 1% to as many U.S. patients as we can remains resolute. We are currently focused on preparing for the commercial launch of VTAMA cream, subject to FDA approval, for its second U.S. indication of atopic dermatitis, and look forward to the PDUFA date for our sNDA in Q4 2024.”
In 2020, Dermavant licensed Japan rights to Japan Tobacco to develop and commercialize tapinarof for psoriasis and atopic dermatitis Under the terms of the 2020 license agreement, Dermavant received an upfront payment of $60 million, with up to a further $53 million payable upon the achievement of certain development milestones for tapinarof for the treatment of psoriasis and atopic dermatitis including $28 million for approval in Japan. In addition, Dermavant has the right to receive royalties based on product sales of tapinarof in Japan.
