FDA Approves Tapinarof Cream, 1% for Adults with Plaque Psoriasis

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This approval makes tapinarof cream the first and only FDA-approved steroid-free topical medication in its class.

Today, the Food and Drug Administration approved tapinarof (VTAMA) cream, 1% for the treatment of plaque psoriasis in adults regardless of disease severity, making it the first and only FDA-approved steroid-free topical medication in its class.

The approval was bolstered by positive data from the PSOARING 1 and PSOARING 2 trials, in which 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.

The aryl hydrocarbon receptor agonist also demonstrated a highly statistically significant improvement in all secondary endpoints of the trials, including a ≥75% in Psoriasis Area and Severity Index (PASI-75) from baseline at week 12.

Notably, the adverse event profile of the topical therapy reported in both trials indicated that a majority of AEs- including folliculitis, nasopharyngitis, and contact dermatitis- were localized to the site of application while being mild to moderate in nature.

“We are delighted with our FDA-approved label for VTAMA cream, which is for adults with psoriasis, regardless of disease severity, and with an unlimited duration of use,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “In anticipation of today’s approval, we have a fully built commercial infrastructure in place, and I am excited to say we will have product in the channel in the first week of June. As the first and only approved drug in its class in the US, the FDA’s approval of VTAMA cream provides an effective new non-steroidal treatment option for millions of adults living with plaque psoriasis and represents a major milestone for Dermavant and its stakeholders”

After the success of the PSOARING.1 and 2 trials, eligible patients had the chance to enroll in PSOARING 3, a phase 3 long term extension (LTE) study in which patients received an additional 40 weeks of open-label treatment with tapinarof cream followed by 4 weeks of follow-up.

Over 40% of Phase 3 LTE study patients (312) achieved complete disease clearance (PGA=0) at least once during the study period.

Notably, the topical cream demonstrated safety and tolerability consistent with PSOARING 1 and PSOARING 2, and treatment emergent adverse events were mostly mild to moderate in nature and restricted to application sites.

“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, FAAD, Dean for Clinical Therapeutics and Waldman Professor and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York and lead author of the Phase 3 studies of VTAMA cream published in The New England Journal of Medicine. “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 and a demonstrated remittive effect of approximately 4 months in patients off therapy.”