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Search Results for: VTAMA® (tapinarof) cream, 1%
Post Atopic Dermatitis

Dermavant Presents ADORING 3 LTE Final Data on Complete Skin Clearance and Treatment-Free Interval for VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as Two Years Old with Atopic Dermatitis at the 44th Annual Fall Clinical Dermatology Conference

— The majority of patients, 51.9% (378/728), entered with or achieved complete disease clearance (vIGA-AD™=0) in the 48-week ADORING 3 open-label LTE study. — — Most patients, 81.6% (594/728), entered with or achieved clear or almost clear skin (vIGA-AD=0 or 1) with VTAMA cream, 1% in the ADORING 3 open-label LTE study. — — Patients […]
Post Atopic Dermatitis

Dermavant Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

— sNDA filing acceptance is based on positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the Phase 3 ADORING 3 open-label, long-term extension trial — — FDA PDUFA Action Expected in Q4 2024 — LONG BEACH, Calif., and BASEL, Switzerland, April 29, 2024 – Dermavant Sciences, […]
Post Atopic Dermatitis

Dermavant Presents New Data on Treatment of Patients with Skin of Color from ADORING 1 and ADORING 2 Phase 3 Pivotal Trials of VTAMA® (tapinarof) Cream, 1% in Adults and Children 2 Years of Age and Older with Atopic Dermatitis at the 2024 American Academy of Dermatology Annual Meeting

— VTAMA cream demonstrated statistically significant efficacy in adults and children down to 2 years of age with atopic dermatitis, in a diverse population comprised of approximately 50% of patients with skin of color — — In ADORING 1 and ADORING 2, 57.1% and 58.1% of patients, respectively, with Fitzpatrick skin type (IV, V, VI) […]
Post Atopic Dermatitis

Dermavant to Present New ADORING Data Including Treatment of Patients with Skin of Color from Phase 3 Trials of VTAMA® (tapinarof) Cream, 1% in Adults and Children 2 Years of Age and Older with Atopic Dermatitis at the 2024 American Academy of Dermatology Annual Meeting

— Four poster presentations, including two oral presentations, will highlight the clinical data for VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older — LONG BEACH, Calif., and BASEL, Switzerland, March 1, 2024 – Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics […]
Post Atopic Dermatitis

Dermavant Submits Supplemental New Drug Application (sNDA) to FDA for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

— sNDA is supported by positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the Phase 3 ADORING 3 open-label, long-term extension trial — — In both ADORING 1 and ADORING 2, VTAMA cream demonstrated highly statistically significant improvement in the primary endpoint of vIGA-ADTM treatment success over […]
Post Atopic Dermatitis

Dermavant Announces Positive Data from the ADORING Phase 3 Development Program in Atopic Dermatitis with VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

— 80.7% (574/711) of patients achieved EASI75 (at least a 75% reduction in disease burden) in an integrated analysis of all the ADORING Program studies — — 77.9% (218/280) of patients ≥12 years old with a baseline PP-NRS (itch) score ≥4 achieved a ≥4-point reduction in PP-NRS. In the ADORING pivotal studies, a mean itch […]
Post Plaque Psoriasis

Dermavant Announces Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Plaque Psoriasis in the Head and Neck Region in Adults

— 88.5% of adult patients achieved a target lesion Physician Global Assessment (tPGA) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at Week 12 (tPGA Success), reinforcing strong efficacy in these areas — — 80.8% of adult patients achieved tPGA score of 0 (clear) at Week 12, indicating complete […]
Post Plaque Psoriasis

Dermavant Presents Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Intertriginous Plaque Psoriasis in Adults at 43rd Annual Fall Clinical Dermatology Conference

— Notably, 82.8% of adult patients achieved an intertriginous Physician Global Assessment (iPGA) Score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at Week 12, demonstrating compelling efficacy. — — Patients experienced a rapid onset of efficacy, with iPGA success occurring, as early as 2 weeks, with a median time […]
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VTAMA® (tapinarof) cream, 1%
Post Atopic Dermatitis

Dermavant Reports Positive Topline Results from ADORING 1, the Second Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

– 45.4% of subjects receiving VTAMA achieved the primary endpoint of vIGA-ADTM response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 13.9% on vehicle (P<0.0001) – – All secondary endpoints were met with statistical significance, including 55.8% of subjects treated with VTAMA who achieved […]

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Important Safety Information

Indications: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for:

  • the topical treatment of plaque psoriasis in adults.
  • the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.

Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis); pain or swelling in the nose and throat (nasopharyngitis); skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis); headache; itching (pruritus); and flu (influenza).

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection; red raised bumps around the hair pores (folliculitis); lower respiratory tract infection; headache; asthma; vomiting; ear infection; pain in extremity; and stomach-area (abdominal) pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information and Patient Information.