FDA Approves First Steroid-Free Psoriasis Treatment
The US Food and Drug Administration (FDA) approved a first-of-its-kind steroid-free topical cream, tapinarof, (VTAMA), 1%, for the treatment of plaque psoriasis in adults.
The approval follows 2 phase 3 studies that tested the safety and efficacy of tapinarof. Participants in the study demonstrated a significant statistical improvement, according to the Physician Global Assessment (PGA) score. In the study, participants reported a score of “clear” (PGA = 0) or “almost clear” (PGA = 1) with a minimum 2-grade improvement compared with a vehicle treatment at 12 weeks. Additionally, tapinarof demonstrated a statistically significant improvement of 75% or greater in the Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at week 12.
Patients who completed the phase 3 studies were eligible to enroll in a phase 3 Long Term Extension (LTE) study that consisted of an additional 40 weeks of treatment with tapinarof, followed by 4 weeks of follow-up. Of the 763 participants of the phase 3 LTE study, 312 participants reported a PGA score of 0 at least once during the study period. For participants randomized to tapinarof in the first clinical study who achieved a PGA of 0 during the 12-week study and continued with the Phase 3 LTE study (n = 73), tapinarof demonstrated a remittive effect with a median duration to first worsening of approximately 4 months.
Based on a follow-up questionnaire provided to phase 3 LTE participants, participants demonstrated consistently high rates of satisfaction across all evaluated parameters with 85.8% of patients noting they could easily manage their psoriasis with tapinarof. There were similar rates of satisfaction for how well the treatment worked, how effective tapinarof was, how quickly tapinarof absorbed, and its consistency.
The most common adverse events reported were folliculitis, nasopharyngitis, and contact dermatitis.
“We believe VTAMA cream has the potential to make a meaningful difference in the lives of patients with plaque psoriasis as well as their healthcare providers,” concluded Philip M. Brown, M.D., J.D., Chief Medical Officer of Dermavant. “We are continuing to leverage our experience and insights with the active ingredient, tapinarof, and potentially other [aryl hydrocarbon receptor] molecules, for potential application to other conditions in dermatology and additional inflammatory and immunology indications.”
FDA approves Deravant’s VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the U.S. in 25 years. News Release. Roivant Sciences; May 24, 2022. Accessed July 28, 2022. https://investor.roivant.com/news-releases/news-release-details/fda-approves-dermavants-vtamar-tapinarof-cream-1-treatment