FDA Approves First Non-Steroid Cream for Psoriasis

The FDA has approved Vtama (tapinarof) for the topical treatment of plaque psoriasis in adults. This is the first steroid-free topical medication in its class. It is approved for mild, moderate, and severe psoriasis with no restrictions on duration of use. Vtama was developed by Dermavant Sciences, a subsidiary of Roivant Sciences.

Vtama is an aryl hydrocarbon receptor agonist and modifies the expression of interleukin-17 and the skin barrier proteins filaggrin and loricrin, which are involved in psoriasis.

“Following 20-plus years of minimal innovation in the topical psoriasis treatment space, I believe the approval of Vtama cream is an important step in establishing a new treatment option for adults with mild, moderate and severe plaque psoriasis,” Mark Lebwohl, M.D., said in a press release. He is dean for Clinical Therapeutics and Waldman Professor and chairman emeritus of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York and lead author of the phase 3 studies of Vtama published in December 2021 in The New England Journal of Medicine.

In the pivotal phase 3 clinical trial program, Vtama met all primary and secondary endpoints and demonstrated highly statistically-significant improvement with 36% of patients in the PSOARING 1 trial and 40% in PSOARING 2 trial achieving clear or almost clear skin at week 12. The median duration of clear or almost clear skin was about four months after cessation of treatment. The majority of adverse events were localized to site of application, and mild to moderate in nature.

About 8 million Americans and 125 million people worldwide are affected by psoriasis, which is a complex autoimmune disease. Plaque psoriasis is the most common form and affects about 80% to 90% of people with psoriasis.