Perspective from Linda Stein Gold, MD
Source:

Press Release

Disclosures: Brown reports being an employee of Dermavant Sciences.
May 24, 2022
1 min read
Save

FDA approves Vtama for topical psoriasis treatment

Perspective from Linda Stein Gold, MD
Source:

Press Release

Disclosures: Brown reports being an employee of Dermavant Sciences.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

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.

FDA approval
The FDA has approved Vtama cream for the treatment of plaque psoriasis in patients with mild, moderate or severe disease.

“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.

Philip Brown

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."