FDA Approves VTAMA® for Adults with Psoriasis

On May 24, 2022, the U.S. Food and Drug Administration (FDA) approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, indicated 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. [1]

This approval is based on findings from PSOARING 1, 2, and 3, with PSOARING 3 being a long-term extension study. During Phase 3 LTE, over 40% of study patients achieved complete disease clearance (PGA=0) at least once during the study period. [1]

“Tapinarof is a novel non-steroidal topical cream approved for psoriasis. It offers once-daily application and a high chance of clearance of the localized psoriasis. Some patients (about 20%) will experience a folliculitis of the skin at the treatment areas, but very few (<2% in the studies) will stop treatment due to this relatively mild side effect. Finally, some patients who clear with the use of tapinarof will note a long period of time that the psoriasis remains clear while not using the medication (remission) before having to use the cream again,” shared Bruce Strober, M.D., Ph.D., a Clinical Professor in the department of dermatology at Yale University School of Medicine, New Haven, Connecticut, and a board certified dermatologist at Central Connecticut Dermatology Research, Cromwell, Connecticut.

Furthermore, data from the Phase 3 LTE study showed consistent and positive patient satisfaction. [1]