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On August 10, 2021, Dermavant Sciences announced that the US FDA has accepted its new drug application (NDA) for the treatment of tapinarof topical cream for the treatment of adult plaque psoriasis (plaque psoriasis)
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
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 molecular structure of Tapinarof (photo source: Edgar181, Public domain, via Wikimedia Commons)
The multicenter, randomized, double-blind, vehicle-controlled PSOARING1 and PSOARING2 trials enrolled 1,025 patients.
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
Psoriasis is a chronic systemic inflammatory skin disease characterized by the appearance of red plaques and plaques with silver scales on the skin, affecting 125 million people worldwide
(The original text has been deleted)
Reference materials:
[1] Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis.