FDA Approves Dermavant's Vtama for Psoriasis

FDA has approved Vtama® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist from Dermavant for the topical treatment of plaque psoriasis in adults. Vtama cream is the first and only FDA-approved steroid-free topical medication in its class. 

Dermavant says it will have product available in the first week of June. 

“As the first and only approved drug in its class in the US, 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,” says Todd Zavodnick, Chief Executive Officer of Dermavant.

“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,” says 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.

Across PSOARING 1 and PSOARING 2, Vtama cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) 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 ≥75% Improvement in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at week 12. 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. 

Over 40% of Phase 3 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 3 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 3 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 3 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. 

In September 2021, Dermavant Sciences dosed its first patient in a Phase 3, double-blind, vehicle-controlled study of tapinarof cream for the treatment of atopic dermatitis (AD) in adults and children. The Phase 3 clinical program will enroll up to 800 patients across two pivotal trials (ADORING 1 and ADORING 2) to evaluate the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 8 weeks versus vehicle cream QD in patients aged 2 years and older. The company anticipates announcing topline results from ADORING 1 and ADORING 2 in 1H 2023.