NDA submitted for tapinarof cream for psoriasis
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A new drug application has been submitted to the FDA for tapinarof cream for the treatment of plaque psoriasis in adults, Dermavant Sciences announced in a press release.
A novel therapeutic aryl hydrocarbon receptor modulating agent, tapinarof cream was shown to significantly improve Physician Global Assessment scores in patients with plaque psoriasis in the PSOARING 1, PSOARING 2 and PSOARING 3 trials.
“Psoriasis impacts approximately 8 million Americans, who have to navigate the physical and emotional toll from this devastating disease,” Todd Zavodnick, Dermavant CEO, said in the release. “Today’s NDA submission marks a significant milestone as we work toward FDA approval of tapinarof for adults with plaque psoriasis and their dermatologists who are looking to fill current treatment gaps. We plan on continuing our commercial preparations to bring this novel product candidate to the U.S. market as expeditiously as possible, subject to regulatory approval.”
The NDA was submitted on May 26, and the FDA has a 60-day review period to decide if it is acceptable for filing.