Vtama FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 17, 2024.
FDA Approved: Yes (First approved May 23, 2022)
Brand name: Vtama
Generic name: tapinarof
Dosage form: Cream
Company: Organon Pharmaceuticals
Treatment for: Plaque Psoriasis, Atopic Dermatitis
Vtama (tapinarof) is a topical aryl hydrocarbon receptor (AhR) modulating agent used for the treatment of plaque psoriasis and atopic dermatitis.
- Vtama is indicated for the:
- topical treatment of plaque psoriasis in adults.
- topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. - Plaque psoriasis is a chronic, immune-mediated, inflammatory disease characterized by patches of thick red skin and silvery scales typically found on the elbows, knees, scalp, lower back, face, palms, and soles of feet. Atopic dermatitis is a common, chronic, inflammatory skin disease characterized by persistent itch and recurrent skin lesions.
- Vtama 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 and dermatitis for more than a century.
- FDA approval for Vtama in the treatment of plaque psoriasis was supported by data from the Phase 3 PSOARING 1 and PSOARING 2 trials, which demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of "clear" or "almost clear" with a minimum 2-grade improvement compared with vehicle from baseline at week 12.
- FDA approval for Vtama in the treatment of atopic dermatitis was supported by data from the ADORING pivotal studies, which demonstrated a statistically significant difference versus vehicle in the proportion of patients achieving a Validated Investigator Global Assessment for AD (vIGA-AD) score of "clear" or "almost clear" and a minimum 2-grade improvement from baseline at Week 8.
- Vtama is applied in a thin layer to affected areas once daily.
- Common adverse reactions (incidence ≥ 1%) in plaque psoriasis patients include folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Common adverse reactions (incidence ≥ 1%) in atopic dermatitis patients include upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.
Development timeline for Vtama
Further information
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