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Dermavant Sciences Says FDA Approves VTAMA Cream, 1% For Plaque Psoriasis In Adults

Dermavant Sciences, a subsidiary of biopharmaceutical company Roivant Sciences (ROIV), announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved VTAMA (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults.

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

Across PSOARING 1 and PSOARING 2, VTAMA cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of "clear" or "almost clear" with a minimum 2-grade improvement compared with vehicle from baseline at week 12.

VTAMA cream also demonstrated a highly statistically significant improvement in all secondary endpoints versus vehicle, including =75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline at week 127.

The adverse event (AE) profile of VTAMA cream reported in both PSOARING 1 and PSOARING 2 demonstrated that the majority of AEs were localized to the site of application and were mild to moderate in nature. The most common AEs of subjects treated with VTAMA cream were folliculitis, nasopharyngitis, and contact dermatitis.

Eligible patients who completed PSOARING 1 or PSOARING 2 could enroll in PSOARING 3, a Phase 3 Long Term Extension (LTE) study, which consisted of an additional 40 weeks of open-label treatment with VTAMA cream, followed by a four-week follow-up.

Over 40% of Phase 3 LTE study patients achieved complete disease clearance at least once during the study period.

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