Benvitimod

The American Academy of Dermatology (AAD) provides a strong evidence-based recommendation for the use of VTAMA cream in adults with moderate to severe atopic dermatitis (AD), the most common form of eczema. Recommendation reflects VTAMA cream’s proven efficacy, safety, and tolerability as a steroid-free, topical aryl hydrocarbon receptor agonist. AD impacts 26 million people in the United States, 16.5 million of which are adults. JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, today announced that VTAMA® (tapinarof) cream, 1%, was granted a strong recommendation by the American Academy of Dermatology (AAD) in their 2025 focused guideline update for the management of adults with moderate to severe atopic dermatitis (AD). The recommendation underscores VTAMA cream as an effective, steroid-free option for daily disease management, with no label warnings or precautions, no contraindications, and no restrictions on duration of use or percentage of body surface area affected. In AD, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. “With 6.6 million adults in the US living with moderate to severe AD, innovative treatment options that meet the highest standards for efficacy, safety, and tolerability are necessary to help provide lasting relief. We are proud of the AAD’s strong evidence-based recommendation from the ADORING 1 and ADORING 2 8-week clinical trials for VTAMA cream—a once daily, steroid-free topical with no label restrictions on use based on disease severity, percentage of body surface area affected, or duration of use,” said Juan Camilo Arjona Ferreira, Head of Research and Development and Chief Medical Officer at Organon. “This strong recommendation, paired with the findings from our Phase 3 ADORING 3 48-week, open-label, long-term extension study which uncovered the possibility of a treatment-free interval lasting on average 80 days after treatment success, highlights how VTAMA cream has the potential to redefine the AD treatment landscape and provide lasting results.” The focused update incorporates topical and systemic therapies that have been recently approved by the US Food and Drug Administration (FDA) into the AAD’s existing guidance on the management of AD in adults to ensure the dermatology community has access to the best available evidence. In December 2024, the FDA approved VTAMA cream for the topical treatment of AD in adults and pediatric patients 2 years of age and older. VTAMA cream was also approved by the FDA on May 24, 2022, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults. INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) 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 SELECTED SAFETY INFORMATION Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and 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. Before prescribing VTAMA cream, please read the Prescribing Information. For more information about VTAMA (tapinarof) cream, 1%, visit www.vtamahcp.com. About Atopic Dermatitis AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the US alone and up to 10% of adults worldwide.1,2 AD occurs most frequently in children, affecting up to 20% worldwide.1,2 The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck.3 Itching is an especially bothersome symptom for those with AD, and tends to worsen at night, which can disturb sleep.1 About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook. Cautionary Note Regarding Forward-Looking Statements Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations about the potential impact of VTAMA as a treatment option for AD. Forward-looking statements may be identified by words such as “potential,” “mission,” “expects,” “will,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. ____________________ 1 Eczema stats. National Eczema Association. Accessed June 5, 2025. https://nationaleczema.org/research/eczema-facts/ 2 Global Report on Atopic Dermatitis 2022. International League of Dermatological Societies: 2022. Accessed February 25, 2025. https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf 3 What is eczema? National Eczema Association. Accessed July 2, 2025. https://nationaleczema.org/eczema/