The U.S. regulator has approved Dermavant Sciences' Vtama for the topical treatment of plaque psoriasis — making the cream the first and only FDA-approved steroid-free topical medication in its class.
Although it joins a crowded psoriasis market of pills and injectables, the aryl hydrocarbon receptor agonist is, according to Dermavant, the first topical Novel Chemical Entity launched for psoriasis in the U.S. in 25 years.
The current standard of care for psoriasis is steroids, which come with limitations for the length of time they can be used. Vtama can be used for any length of time and can be applied to all body areas — including on sensitive locations, such as the face or genitals.
Originally developed by GSK, Dermavant, a subsidiary of Roivant Sciences, licensed the phase 3 ready-treatment back in 2018, in a deal worth $330 million.
In two studies, PSOARING 1 and PSOARING 2, Vtama cream demonstrated a highly statistically significant improvement in the assessment of disease severity, called the Physician Global Assessment score, of “clear” or “almost clear.” Eligible patients who completed either study could enroll in PSOARING 3, a phase 3 Long Term Extension (LTE) study, which consisted of an additional 40 weeks of open-label treatment with Vtama followed by a four-week follow-up. Over 40% of phase 3 study patients achieved complete disease clearance (PGA=0) at least once during the study period.
Dermavant says it will "have product in the channel" by the first week of June.
