Recently, Dermavant Sciences announced that the US FDA has accepted its new drug application (NDA) for its investigational therapy tapinarof topical cream for the treatment of adult plaque psoriasis . The PDUFA date for this application is set for the second quarter of 2022.

Tapinarof emulsion is a once-daily aryl hydrocarbon receptor modulator (TAMA) being developed by Dermavant Sciences for the treatment of plaque psoriasis and atopic dermatitis. Aromatic hydrocarbon receptors play an important role in regulating autoimmune responses. Tapinarof can inhibit IL-17-mediated inflammation by regulating the function of aromatic hydrocarbon receptors. It is worth mentioning that this innovative treatment was first approved for marketing in China in 2019. It is called benvitimod cream and is included in the 2020 medical insurance drug catalog.

This application is supported by the positive data obtained from the two phase 3 clinical trials PSOARING 1 and PSOARING 2 for the treatment of patients with psoriasis, and the mid-term results of the long-term safety study PSOARING 3.

The multicenter, randomized, double-blind, carrier-controlled PSOARING1 and PSOARING2 trials enrolled 1,025 patients. Among 18-75-year-old adult patients with plaque psoriasis, the safety of tapinarof (1%) cream was evaluated Sex and effectiveness. Both trials reached their primary endpoint. Test results show that the drug enables about one-fifth of patients to reach the standard of more than 90% improvement in psoriasis area and severity index (PASI 90) after 12 weeks of treatment.

In the open-label PSOARING 3 extension study, patients who had participated in the pivotal phase 3 clinical trials PSOARING 1 and PSOARING 2 continued to receive 40 weeks of tapinarof treatment. The mid-term results showed that 57.3% of subjects with skin symptoms reached the doctor’s overall assessment (PGA) score of 0 (representing complete removal of skin symptoms) or 1 (almost complete removal of skin symptoms) after receiving treatment, meaning that With the prolonged use of tapinarof, it shows better curative effect. In addition, its effect can be maintained for 4 months after stopping the drug, which can help patients who have been plagued by psoriasis for a long time to control the symptoms of the disease.