Tapinarof Approved in Japan for Psoriasis and Atopic Dermatitis, Announces Dermavant

Dermavant Sciences Inc., a biopharmaceutical company focusing on innovative treatments in immuno-dermatology, has announced a significant milestone. Japan Tobacco has secured approval in Japan for tapinarof cream, 1%, for treating adults with psoriasis and patients aged 12 and older with atopic dermatitis. This approval underscores the potential of tapinarof as a unique, once-daily, steroid-free topical treatment for both acute and long-term management of these skin conditions.

Todd Zavodnick, CEO of Dermavant, emphasized the importance of this approval, highlighting tapinarof’s unique attributes and applauding Japan Tobacco's achievement. Zavodnick reaffirmed Dermavant's commitment to bringing VTAMA (tapinarof) cream, 1%, to U.S. patients, particularly for its new indication in atopic dermatitis, pending FDA approval.

In 2020, Dermavant licensed the rights for Japan to Japan Tobacco for the development and commercialization of tapinarof for psoriasis and atopic dermatitis. Under this agreement, Dermavant received an upfront payment of $60 million, with potential additional payments totaling up to $53 million for specific development milestones, including $28 million for the approval in Japan. Dermavant also retains the right to receive royalties from product sales in Japan.

VTAMA cream, 1% is an aryl hydrocarbon receptor agonist currently approved in the U.S. for treating plaque psoriasis in adults. It is a novel, once-daily, cosmetically appealing, steroid-free topical cream designed for both acute and long-term management of atopic dermatitis (AD) and psoriasis. In April 2024, the FDA accepted Dermavant’s Supplemental New Drug Application (sNDA) for VTAMA cream, 1% for treating AD in adults and children aged two and older, with a Prescription Drug User Fee Act (PDUFA) action date set for Q4 2024.

Atopic dermatitis, commonly known as eczema, is a prevalent inflammatory skin disease affecting over 26 million people in the U.S. and up to 10% of adults globally. It is most frequent in children, affecting up to 20% worldwide. The disease is characterized by itchy, red, swollen, and cracked skin, primarily appearing on the folds of the arms, back of the knees, hands, face, and neck. The itching often worsens at night, leading to sleep disturbances and fatigue, which can impact children's attention at school. The visibility and discomfort of the disease can also cause significant social and emotional distress.

Dermavant Sciences, a subsidiary of Roivant Sciences, is dedicated to developing and commercializing innovative treatments in immuno-dermatology. The company aims to address high unmet medical needs while enhancing efficiency in research and clinical development. Dermavant’s pipeline includes early-stage, late-stage, and commercialized product candidates targeting plaque psoriasis and atopic dermatitis, among other immunological and inflammatory diseases. VTAMA cream, 1%, is currently marketed for treating plaque psoriasis in adults, following its FDA approval in May 2022 for mild, moderate, and severe cases. Dermavant has reported positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials for treating atopic dermatitis in adults and children aged two and older in the first half of 2023.

Overall, Dermavant’s advancements in developing and commercializing VTAMA cream, 1%, demonstrate significant progress in addressing critical needs in immuno-dermatology, particularly for conditions like psoriasis and atopic dermatitis. The company's continued efforts in expanding the therapeutic applications of VTAMA cream hold promise for improving the quality of life for patients suffering from these chronic skin diseases.