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The FDA has approved the first topical novel therapy for psoriasis in 25 years, .

Tapinarof cream 1% (Vtama) received an indication for mild, moderate, and severe plaque psoriasis in adults. The approval carries no restrictions on duration of use or body surface area.

An aryl hydrocarbon receptor agonist, tapinarof cream represents a new nonsteroidal option for plaque psoriasis.

"Following 20-plus years of minimal innovation in the topical psoriasis treatment space, I believe the approval of Vtama cream is an important step in establishing a new treatment option for adults with mild, moderate, and severe plaque psoriasis," said Mark Lebwohl, MD, of the Icahn School of Medicine at Mount Sinai in New York City, in a statement from Roivant Sciences. "As a clinician, I'm excited to finally have a versatile, once-daily, steroid-free topical treatment that is backed by extensive clinical trial data supporting its favorable safety and efficacy profile."

Support for the approval came from the PSOARING 1 and PSOARING 2 randomized, phase III, vehicle-controlled clinical trials. In both trials, 35-40% of patients treated with tapinarof cream met the primary endpoint of Physician Global Assessment (PGA) scores of clear or almost clear, plus at least a two-grade improvement in PGA score at 12 weeks when treated with tapinarof cream versus 5-6% of the control groups. Analysis of all key secondary outcomes showed statistically significant improvement with tapinarof.

A 40-week open-label extension trial showed that more than 40% of patients achieved PGA=0 (complete clearance) at least once during the follow-up period.

The safety profile of tapinarof during the randomized phase of both trials showed that most adverse events were mild or moderate and localized to the application site. The most common adverse events associated with tapinarof cream were folliculitis, nasopharyngitis, and contact dermatitis. The duration of remittive effect off therapy averaged 130 days.

Tapinarof cream 1% is being evaluated in two ongoing phase III trials of adults and children with atopic dermatitis, according to the statement. Initial results are expected by mid-2023.

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