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FDA approves Vtama topical cream to treat psoriasis.

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Published:25th May 2022

Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, announced that the FDA has approved Vtama (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults.

Across PSOARING 1 and PSOARING 2, Vtama cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA)6 score of “clear” (PGA=0) or “almost clear” (PGA=1) 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 greater than 75% Improvement in Psoriasis Area and Severity Index (PASI) score (PASI-75) 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 III 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. As such, patients who were randomized to Vtama cream in PSOARING 1 or PSOARING 2 and who also completed the Phase III LTE study received Vtama cream treatment for up to 52 weeks. 92% of patients who completed PSOARING 1 and PSOARING 2 enrolled in the Phase III LTE study.

Over 40% of Phase III LTE study patients (n=312/763) achieved complete disease clearance (PGA=0) at least once during the study period. For patients randomized to Vtama cream in PSOARING 1 and PSOARING 2 who achieved a PGA of 0 during the 12-week study and subsequently enrolled in the Phase III LTE study (n=73), Vtama cream demonstrated a remittive effect (maintenance of PGA of 0 or 1 while off therapy) with a median duration to first worsening of approximately four months. Among a larger cohort of patients who either entered the Phase III LTE study with a PGA score of 0 or achieved one during the LTE study (n=312), the mean duration of remittive effect off-therapy was 130 days.

In the Phase III LTE study, VTAMA cream demonstrated safety and tolerability consistent with PSOARING 1 and PSOARING 2. Treatment emergent adverse events were mostly mild to moderate in nature and restricted to application sites.

Responses to a questionnaire, which were assessed at Phase III LTE study completion (week 40 or early termination), demonstrated consistent high rates of satisfaction across all evaluated parameters. Of the 78.5% (n=599) of patients from Phase III LTE study who completed the survey: 85.8% of patients felt they could easily manage their psoriasis with Vtama cream; 83.6% were satisfied with how well Vtama cream worked; 81.7% considered it more effective than prior topical treatments, and most patients strongly agreed or agreed Vtama cream absorbed quickly (89.5%), was not greasy (89.0%), and felt good on their skin (79.9%).

Condition: Psoriasis
Type: drug

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