Vtama FDA Approval History
Last updated by Judith Stewart, BPharm on May 25, 2022.
FDA Approved: Yes (First approved May 23, 2022)
Brand name: Vtama
Generic name: tapinarof
Dosage form: Cream
Company: Dermavant Sciences
Treatment for: Plaque Psoriasis
Vtama (tapinarof) is a topical aryl hydrocarbon receptor (AhR) modulating agent indicated for the treatment of plaque psoriasis in adults.
- Psoriasis is a chronic, immune-mediated, inflammatory disease that is pathogenically driven by pro-inflammatory cytokines.
- Vtama (tapinarof) works by binding and activating AhR to reduce inflammation through the downregulation of pro-inflammatory cytokines, including interleukin 17. The mechanism of action is thought to be similar to that of topical coal tar, which has been used in the treatment of psoriasis for more than a century.
- 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.
- Vtama is applied in a thin layer to affected areas once daily.
- Common adverse reactions include folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Development timeline for Vtama
Further information
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