The American Academy of Dermatology (AAD) provided a strong, evidence-based recommendation for the use of VTAMA cream, the only steroid-free topical treatment the AAD found to be supported by a high certainty of evidence that is indicated across all severities in children aged 2 years and older with atopic dermatitis (AD) This recommendation reflects the proven efficacy, safety, and tolerability of VTAMA cream as a first-in-class, steroid-free, topical aryl hydrocarbon receptor (AhR) agonist for children and adolescents with AD AD, the most common form of eczema, impacts nearly 10 million children in the US Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that VTAMA cream was granted a strong, evidence-based recommendation by the American Academy of Dermatology (AAD) in their 2026 guidelines for the management and treatment of atopic dermatitis (AD) in pediatric patients, published
https://www.organon.com/news/organons-vtama-tapinarof-cream-1-granted-strong-recommendation-in-the-2026-american-academy-of-dermatology-guidelines-for-pediatric-atopic-dermatitis/
VTAMA demonstrated early and consistent response rates in disease severity and itch improvements, measured by the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) and Peak Pruritus-Numeric Rating Scale (PP-NRS) with results seen as early as week 1, and continued through week 8 Statistically significant ≥75% improvement in Eczema Area and Severity Index (EASI75) response was achieved as early as week 1 and continued through week 8 Improvements in Eczema Area and Severity Index (EASI) scores were achieved by the majority of patients (96.9%) from baseline at week 8 Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present results from a post-hoc sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating the efficacy and safety of VTAMA cream versus vehicle in an oral session at the 2026 American Academy of Dermatology (AAD) Annual Meeting
https://www.organon.com/news/organon-debuts-new-analysis-of-vtama-tapinarof-cream-1-phase-3-pooled-data-demonstrating-early-and-consistent-skin-clearance-and-itch-improvement-in-atopic-dermatitis-patients-down-to-2-year/
Clinically meaningful improvements in sleep scores, as measured by subdomains of the Patient-Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI) assessments, were observed as early as week 1 and continued through week 8 Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, Pennsylvania, on February 27, 2026. The findings show that VTAMA cream provided early and consistent improvements in the POEM sleep subdomain for pediatric patients down to age 2 with moderate to severe atopic dermatitis (AD) and in the DFI sleep subdomain for family members of patients aged 2-15 years. “Sleep disturbance is a significant problem for children with atopic
https://www.organon.com/news/new-analysis-of-organons-vtama-tapinarof-cream-1-phase-3-data-showed-early-and-consistent-improvement-in-patient-reported-sleep-subdomains-in-pediatric-patients-down-to-2-years-of-a/
Low disease activity was observed after a mean duration of 80 consecutive days off-treatment following success with VTAMA cream, with a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9 at the end of the treatment-free interval Data presented as late breaker at 2025 American Academy of Dermatology (AAD) Annual Meeting JERSEY CITY, N.J.-(BUSINESS WIRE)- Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced results from an analysis of the Phase 3 ADORING 3 open-label, long-term extension study evaluating VTAMA ® (tapinarof) cream, 1% once daily in adults and children 2 years of age and older with atopic dermatitis (AD), also known as eczema. The findings demonstrate that AD disease activity remained mild in patients who had achieved treatment success and subsequently entered a treatment-free interval lasting on average 80 days. These results were presented during a late-breaking research session today at the 2025 American
https://www.organon.com/news/new-analysis-of-organons-vtama-tapinarof-cream-1-phase-3-data-shows-atopic-dermatitis-disease-activity-remained-low-after-treatment-free-interval-in-adults-and-children-2-years-of-ag/
EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on VTAMA cream achieved vIGA-AD™ treatment success at Week 8 versus 18% of patients on vehicle. POWERFUL SKIN CLEARANCE: The majority of patients entered with or achieved complete disease clearance (vIGA-AD=0) at least once in the 48-week open-label ADORING long-term extension (LTE) study and remained treatment-free (remittive effect) for an average of ~80 consecutive days. RAPID ITCH RELIEF: Itch improvement as early as 24 hours after first application of VTAMA cream was reported by patients and caregivers. SAFE AND TOLERABLE: VTAMA cream demonstrated a favorable and consistent safety profile in both the 8-week pivotal studies and the 48-week long-term extension (LTE) study; and was well-tolerated, including on affected sensitive skin areas. Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug
https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/
Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA ® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12, 2024. The FDA has not raised any concerns regarding the safety and efficacy of VTAMA nor have they raised any concerns regarding the approvability of this indication. As part of its review process, the FDA requested the final datasets and clinical study report from the long-term extension study for VTAMA. After receiving the datasets, the FDA determined that the additional information requested constitutes a major amendment to the sNDA resulting in a standard three-month
https://www.organon.com/news/update-on-fda-review-of-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/
The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S. Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. Please see our prior announcement for a summary of the transaction terms . VTAMA ® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a supplemental New Drug Application (sNDA) for VTAMA cream as a potential treatment
https://www.organon.com/news/organon-completes-acquisition-of-dermavant-including-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/
VTAMA cream is a novel, non-steroidal topical therapy approved for treatment of plaque psoriasis in adults and is under FDA review for an additional indication to treat atopic dermatitis Proposed acquisition extends Organon’s international dermatology capabilities to the U.S. JERSEY CITY, N.J., September 18, 2024 – Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, and Dermavant Sciences Ltd. announced today that they have entered into a definitive agreement, under which Organon will acquire Dermavant, a Roivant (NASDAQ: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s novel product, VTAMA® (tapinarof) cream, 1%, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the U.S. Food and Drug Administration (FDA) in May 2022. VTAMA cream is a once-daily, steroid-free, topical applied to affected areas with no
https://www.organon.com/news/organon-to-acquire-dermavant-including-its-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/
— 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, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Supplemental New Drug Application (sNDA) for VTAMA ® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. The Prescription Drug User Fee Act (“PDUFA”) action date assigned by the Agency is in Q4 2024. VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management
https://www.organon.com/news/dermavant-issued-release-dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-chil/