Dermavant’s Vtama (tapinarof) Receives the US FDA’s Approval for the Treatment of Plaque Psoriasis in Adults
Shots:
- The P-III (PSOARING 1 & 2) trial met all 1EPs & 2EPs i.e., Vtama showed an improvement in PGA 6 score of “clear” or “almost clear” with a minimum 2-grade improvement (36% & 40% vs 6% & 6%) @12wks., ≥75% improvement in PASI-75 from baseline
- 92% were enrolled in the P-III LTE study who completed (PSOARING 1 & 2) trial, 40% of LTE study patients achieved complete disease clearance, remitting effect with a median duration of ~4mos. while in off-therapy was 130 days who achieved clear skin PGA score of 0 or 1
- The safety & tolerability was consistent with PSOARING 1/2/3 study. Patient satisfaction data from the P-III LTE study showed that 81.7% considered it more effective than prior topical treatments. The product is expected to be available in June 2022
Ref: Dermavant | Image: Dermavant
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