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Dr. Brown and Mr. Zavodnick speak on the first and only FDA-approved steroid-free topical medication in its class approved for psoriasis, and the data that bolstered this approval.
Last week, the US Food and Drug Administration approved tapinarof cream, 1% (VTAMA) for the treatment of plaque psoriasis of all severities in adult patients, ushering in the first and only FDA-approved steroid-free topical medication in its class.
Remarkably, it had been 25 years since a novel chemical entity had been introduced into psoriasis care from a brand-new mechanism of action, and from the data gathered from the phase 3 PSOARING 1 and 2 trials as well as the long term extension (LTE) study, it couldn’t have come at a better time.
Pivotal phase 3 data showed treatment with tapinarof cream led to statistically significant improvements in Physician Global Assessment (PGA) score of “clear” or “almost clear” with a minimum 2-grade improvement compared with vehicle treatment from baseline to week 12.
Better yet, the median duration of clear or almost clear skin was approximately 4 months after cessation of treatment with tapinarof cream, which was detailed in the phase 3 LTE study for patients who achieved clear skin (PGA 0) during PSOARING 1 or 2.
“I think the patients that participated and had exposure to the product for up to a year, were indicating that to us that (tapinarof cream) was easy to use, it was extremely well tolerated, it had remarkable impact on their disease, and the fact that they can discontinue therapy for an extended period of time is absolutely incredible,” said Philip Brown, MD, JD, Chief Medical Officer at Dermavant Sciences.
For this episode of DocTalk, Brown and Chief Executive Officer Todd Zavodnick joined the program to speak to the implications of the FDA decision, and how tapinarof cream is set to revolutionize psoriasis management.
“It is unheard of in a topical medicine; when you talk about remittance and staying clear for that time, you're always talking about injectable medicine,” Zavodnick said. “And we're talking about a topical, that's going to allow cost control within a category and the ability to move from steroids to nonsteroidals. So, to us it's extremely exciting.”
Though great strides in psoriatic care have been made in the biologic and systemic space, both Zavodnick and Brown are hopeful that the advancements made with tapinarof cream will usher in a new wave of chemical entities that will improve patient’s live in the psoriasis space and beyond.
“I'm really proud and hopeful of what we're going to do, and how many thousands and tens of thousands of people's lives we will change positively through this experience,” Brown said. “And equally important, I hope it serves as a stimulus or an illustration to industry to be more creative in the way they're thinking about topical products and how we serve patient’s needs.”