Dermavant Receives Approval of Tapinarof for Psoriasis and Atopic Dermatitis in Japan

Dermavant Sciences announced that Japan Tobacco has received approval in Japan for tapinarof cream 1% for the treatment of both adults with psoriasis and patients 12 years of age and older with atopic dermatitis.

“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,” Todd Zavodnick, Chief Executive Officer of Dermavant, said in a company news release. “Our commitment to bringing Vtama (tapinarof) cream, 1% to as many US 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 supplemental new drug application in Q4 2024.”

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.

Vtama cream, 1% is a novel, aryl hydrocarbon receptor agonist in development in the US as a once-daily, steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD). Vtama cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the US. In April 2024, the FDA accepted the company’s supplemental NDA for Vtama (tapinarof) cream, 1% for the topical treatment of AD in adults and children 2 years of age and older. The Prescription Drug User Fee Act (PDUFA) action date assigned by the Agency is in Q4 2024.