FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years

EFFICACY: In the pivotal Phase 3 clinical trial program, VTAMA cream met all primary and secondary endpoints and demonstrated highly statistically significant improvement versus vehicle in Physician Global Assessment (PGA) score with 36% of patients versus 6% in vehicle in PSOARING 1 and 40% of patients versus 6% in vehicle in PSOARING 2 achieving clear or almost clear with a minimum 2-grade improvement at week 12 (p<0.0001 for both trials) –

– REMITTIVE EFFECT: The median duration of clear or almost clear skin was approximately four months after cessation of treatment with VTAMA cream as measured by the time to first worsening while off-therapy during the Phase 3 Long Term Extension (LTE) study for patients who achieved clear skin (PGA 0) on VTAMA cream during PSOARING 1 or 2 –

– DURABILITY: Durability of response up to 52 weeks was demonstrated with intermittent use of VTAMA cream, with no observation of tachyphylaxis (loss of response) while on therapy –

– SAFE AND WELL-TOLERATED, EVEN ON SENSITIVE SKIN AREAS: The safety profile and favorable tolerability of VTAMA cream reported was consistent across PSOARING 1, PSOARING 2 and the Phase 3 LTE, with the majority of adverse events (AEs) localized to site of application, and mild to moderate in nature –

– PATIENT OBSERVATIONS: Patient satisfaction data from the Phase 3 LTE study demonstrated a consistent and positive perception of VTAMA cream across many measures, with 81.7% considering it more effective than prior topical treatments –

– Approved for mild, moderate, and severe psoriasis with no restrictions on duration of use or body surface and remittive effect on-label. Dermavant is prepared for a June 2022 launch with product and sample manufacturing runs completed and a fully staffed commercial team. Conference call and webcast on Tuesday, May 24, 2022, at 8:00 a.m. ET –

LONG BEACH, Calif., and BASEL, Switzerland, May 24, 2022—Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA^® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults. This approval makes VTAMA cream the first and only FDA-approved steroid-free topical medication in its class.

“We are delighted with our FDA-approved label for VTAMA cream, which is for adults with psoriasis, regardless of disease severity, and with an unlimited duration of use. In anticipation of today’s approval, we have a fully built commercial infrastructure in place, and I am excited to say we will have product in the channel in the first week of June. As the first and only approved drug in its class in the U.S., the FDA’s approval of VTAMA cream provides an effective new non-steroidal treatment option for millions of adults living with plaque psoriasis and represents a major milestone for Dermavant and its stakeholders,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “At Dermavant, we are committed to advancing novel, patient-focused innovation in immuno-dermatology. As such, we are proud to have developed a topical treatment in VTAMA cream that provides not only efficacy over 52 weeks but can also be used on all body areas, including on sensitive locations, such as face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae. In addition, an approximately four month off-treatment remittive effect (median time to first worsening), leads us to believe that VTAMA cream has the potential to become the preferred topical option for this chronically underserved patient population and among the physicians who treat them.”

“Following 20-plus years of minimal innovation in the topical psoriasis treatment space^1,2,3,4, 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 ,” said Mark Lebwohl, MD, FAAD, 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 cream published in The New England Journal of Medicine. “As a clinician, I’m excited to finally have a versatile, once-daily, steroid-free topical treatment that is backed by extensive clinical trial data supporting its favorable safety and efficacy profile and a demonstrated remittive effect of approximately four months in patients off therapy.”

Across PSOARING 1 and PSOARING 2, VTAMA cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA)⁶ score of “clear” (PGA=0) or “almost clear” (PGA=1) with a minimum 2-grade improvement compared with vehicle from baseline at week 12. VTAMA cream also demonstrated a highly statistically significant improvement in all secondary endpoints versus vehicle, including ≥75% Improvement in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at week 12⁷. The adverse event (AE) profile of VTAMA cream reported in both PSOARING 1 and PSOARING 2 demonstrated that the majority of AEs were localized to the site of application and were mild to moderate in nature. The most common AEs of subjects treated with VTAMA cream were folliculitis, nasopharyngitis, and contact dermatitis.

1. Psomadakis CE, Han G. J Clin Aesthet Dermatol. 2019;12(12):28-34
2. National Psoriasis Foundation. Two Centuries of Progress in One Short Timeline. Available at: https://www.psoriasis.org/advance/two-centuries-of-progress-in-one-short-timeline/. Accessed August 20, 2021.
3. Federman DG, Froelich CW, Kirsner RS. Am Fam Physician. 1999;59(4):957-962.
4. Goldfarb MT, et al. Mayo Clin Proc. 1987;62:1161-1164.
5. Wu J, Lu M, Veverka K, et al. The journey for US psoriasis patients prescribed a topical: a retrospective database evaluation of patient progression to oral and/or biologic treatment. Journal of Dermatological Treatment. 2018;30(5):446-453.
6. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021; 84: 432-70.
7. Lebwohl M, Stein Gold L, Strober B, et al. Poster presentation at the Fall Clinical Dermatology Conference 2020. Oct 29–Nov 1, 2020.