Vtama (Tapinarof) Cream for Psoriasis Gets FDA Approval

            Vtama (tapinarof), the first new topical psoriasis drug to get the agency’s okay in 25 years, is set to launch in early June.

        On May 24, the U.S. Food and Drug Administration (FDA) approved Vtama (tapinarof) cream 1 percent for the treatment of mild, moderate, or severe plaque psoriasis in adults.

      It is the first unique topical medication to be launched for psoriasis in 25 years, according to a statement by Dermavant, Vtama’s manufacturer.

    “There’s tremendous enthusiasm for this product, in part because of the huge need for new treatments for people who have mild psoriasis,” says dermatologist Steven Feldman, MD, PhD, a psoriasis specialist at Atrium Health Wake Forest Baptist in Winston Salem, North Carolina. (Dr. Feldman is not affiliated with Dermavant and did not participate in any of the clinical trials.)

      Tapinarof represents the first new topical chemical entity for the treatment of psoriasis in 25 years. Tapinarof is a novel, first-in-class, nonsteroidal, small-molecule topical aryl hydrocarbon receptor agonist which works intracellularly to decrease the expression of Th17 cytokines, including interleukin (IL)-17A and IL-17F, reducing inflammation. It also reduces oxidative stress and normalizes the skin barrier.

        Tapinarof is a 1% cream formulation that was studied once daily for 12 weeks in phase 3 clinical trials in mild, moderate and severe patients with body surface areas of 3% to 20%. Up to 40% of patients achieved clear or almost clear IGA response at week 12 with a 2-grade improvement. In the long term studies, patients who entered the study with clear skin had an average remittive response of 4 months.

        Tolerability of the drug was good even in sensitive areas. The most common side effects of folliculitis and contact dermatitis were generally mild to moderate.  

        Tapinarof offers us a drug that is effective, well tolerated and able to be used on multiple body sites including the face and sensitive areas. It provides the possibility of a durable remittive effect that may allow patient to have a drug holiday for several months. I see this as an important new tool to help our psoriasis patients achieve success.