Tapinarof may mark Dermavant’s first atopic dermatitis approval, says GlobalData
June 13, 2024 – Drug Discovery, Pharmaceutical – GlobalData, approval, clinical trials, dermatitis, tapinarof
Dermavant’s VTAMA (tapinarof), a nonsteroidal, topical AhR-modulating agent, achieved positive phase 3 trial results in atopic dermatitis patients aged two and above, leading to Food and Drug Administration (FDA) acceptance of its supplemental new drug application (sNDA). The promising results may bring Dermavant’s VTAMA closer to market authorization and will be its first atopic dermatitis (AD) marketed drug, subject to approval, according to GlobalData, a leading data and analytics company.
Tapinarof activates the NRF-2 pathway, modulating type 17 helper T cytokines and inducing antioxidative enzymes, thereby inhibiting inflammatory pathways.
Filippos Maniatis, healthcare analyst at GlobalData, comments: “The promising phase 3 results for tapinarof marks a milestone for Dermavant, as they bring it one step closer to market authorisation for its asset for the treatment of AD patients two years of age and older. However, it needs to be noted that the competition for Dermavant will be high, as there are multiple topical therapies marketed for AD.”
As Dermavant’s VTAMA has been marketed for adult patients with plaque psoriasis (approved in May 2022 by the FDA) its mechanism of action (MoA) may be a promising therapy for AD, with clinical trials showing good tolerance, with minimal adverse effects in patients with AD, hinting at an opportunity for future therapies that may employ a similar mechanism. Tapinarof is a first-in-class molecule that employs the binding of the aryl hydrocarbon receptor (AhR) to decrease proinflammatory cytokines, decrease oxidative stress, and promote skin barrier normalization.
According to GlobalData’s Pharmaceutical Intelligence Center, the pipeline landscape for topical treatments against AD includes innovator assets such as Jiangsu Hengrui Medicine’s ivarmacitinib sulfate (China) and Arcutis’s roflumilast (US, Canada), currently in phase 3 and pre-registration, respectively.
Other innovator topical pipeline assets include Suzhou Zelgen Biopharmaceutical’s jaktinib hydrochloride, Minghui Pharmaceutical’s MH-004, Maruho’s M-6100, Beijing Puqi Pharmaceutical Technology’s PG-011, Shanghai Thederma Pharmaceuticals’s TAP-1503, and Tianjin Institute of Pharmaceutical Research’s diflucortolone, all of which are in phase 3 development.
In addition, GlobalData has estimated tapinarof’s sales to reach $766 million by 2030 globally for AD, subject to approval, showcasing the potential opportunities in the field of AD.
Maniatis concludes: “Although the competition is already high in the pipeline landscape for AD, Dermavant’s tapinarof minimal adverse effects may be a competitive advantage compared to other therapies that are in development.”
About GlobalData : 4,000 of the world’s largest companies, including over 70% of FTSE 100 and 60% of Fortune 100 companies, make more timely and better business decisions thanks to GlobalData’s unique data, expert analysis and innovative solutions, all in one platform. GlobalData’s mission is to help our clients decode the future to be more successful and innovative across a range of industries, including the https://www.globaldata.com/
About Dermavant: Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Visit: https://dermavant.com/
