Japan Tobacco + Torii submit tapinarof cream to treat atopic dermatitis and psoriasis in Japan.
Japan Tobacco on September 15 filed a new drug application for tapinarof cream, a topical aryl hydrocarbon receptor agonist licensed from Swiss partner Dermavant Sciences, for the treatment of atopic dermatitis and plaque psoriasis in Japan.
A submission is announced by JT and subsidiary Torii Pharmaceutical the same day, is primarily supported by data from Japanese PIII studies respectively in atopic dermatitis (patients aged 12 and above) and plaque psoriasis. Under its licensing pact with Dermavant, JT has acquired the exclusive rights to develop and commercialize the drug for dermatological diseases and conditions in Japan. If approved, the drug will be marketed by Torii.
In the US, tapinarof cream was approved in May 2022 for the indication of plaque psoriasis. In Japan, a pediatric PIII trial is underway targeting children with atopic dermatitis aged 2-11.