FDA approves Vtama for topical psoriasis treatment
The FDA has approved Vtama cream for the treatment of plaque psoriasis in patients with mild, moderate or severe disease, Dermavant Sciences announced.
Vtama (tapinarof) 1%, an aryl hydrocarbon receptor agonist, is the first topical drug approved for the treatment of psoriasis in more than 25 years and the only nonsteroidal drug approved for this indication.
“Vtama represents a sort of watershed moment in dermatology. We’ve seen great innovation on the systemic side of the equation, but it’s really been lacking in regard to topicals,” Philip Brown, MD, JD, chief medical officer at Dermavant Sciences, told Healio. “Vtama represents a new benchmark as it comes into the environment that will enable patients to treat their condition anywhere on their body for any length of time.”
The approval was based on data from the PSOARING 1 and 2 phase 3 trials, as well as the PSOARING 3 long-term extension (LTE) study.
A statistically significant improvement in PGA score of clear or almost clear, with at least a 2-grade improvement at week 12 was achieved in 36% of patients using Vtama in the PSOARING 1 trial and 40% of those in the PSOARING 2 trial, compared to 6% of those in each respective vehicle arm.
In the LTE study, 40% of patients who achieved a PGA of 0/1 during the initial trials showed a remittive effect while off therapy for a median of 4 months.
“We believe this is a highly differentiating characteristic for Vtama and a very novel observation for a topical product,” Brown said. “We believe this is going to have a significant place within the dermatology armamentarium for the management of psoriasis."