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. 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
https://www.organon.com/news/organons-vtama-tapinarof-cream-1-granted-strong-recommendation-in-the-american-academy-of-dermatology-updated-2025-guidelines-for-adult-atopic-dermatitis/
HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab)1,2 The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis3 An interchangeable biosimilar product may be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws4 Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira ® (adalimumab). 2 These interchangeability designations follow the interchangeability
https://www.organon.com/news/us-food-and-drug-administration-fda-grants-interchangeability-designation-to-samsung-bioepis-and-organon-hadlima-adalimumab-bwwd-injection/
Company affirms full year 2025 financial guidance, resets dividend payout to strengthen capital structure Guidance ranges for full year 2025 revenue and Adjusted EBITDA margin are affirmed; company expects to generate over $900 million of free cash flow before one-time costs in 2025 Vtama on track to achieve $150 million revenue target for full year 2025; double-digit growth in Nexplanon in the first quarter Company resets capital allocation priorities to accelerate progress towards deleveraging; new annual regular dividend rate of $0.08 per share First quarter 2025 revenue of $1.513 billion, down 7% as-reported and down 4% at constant currency, consistent with company’s expectations First quarter 2025 diluted earnings per share of $0.33 and non-GAAP Adjusted diluted earnings per share of $1.02 First quarter 2025 net income of $87 million and Adjusted EBITDA (non-GAAP) of $484 million, representing an Adjusted EBITDA margin of 32.0% Organon (NYSE: OGN) today announced its results for
https://www.organon.com/news/organon-reports-results-for-the-first-quarter-ended-march-31-2025/
From personal experiences to professional passion Rania Haggag’s journey into pharmacovigilance did not start in a classroom or office. It began at home, witnessing her mother’s struggle with rheumatoid arthritis (RA). Her journey, particularly with the various medicines to treat the condition, left a lasting impression on Rania. “My passion for this field was ignited […]
https://www.organon.com/stories/reshaping-healthcare-for-women-globally/
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/
We share her stories to amplify her voice and inspire our work
https://www.organon.com/about-organon/stories/
— 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/
Collaboration expands patient access to two products through costplusdrugs.com online pharmacy Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs), has added HADLIMA, an FDA-approved biosimilar to HUMIRA (adalimumab), and NuvaRing to its online pharmacy. At Cost Plus Drugs, HADLIMA is now listed at $1027.62.* This is 85% less than the standard list price of HUMIRA. HADLIMA is available in both citrate-free high concentration (40 mg/0.4 mL), the most-utilized formulation of the originator, and citrate-containing low concentration (40 mg/0.8 mL) formulations to provide patients with continuity of care. All eligible HADLIMA patients, including those who receive HADLIMA through Cost Plus Drugs, may enroll in the “HADLIMA For You” patient support program. HADLIMA was developed, and is manufactured, and supplied by Samsung Bioepis. “Providing patients affordable access to
https://www.organon.com/news/organons-hadlima-adalimumab-bwwd-and-nuvaring-etonogestrel-ethinyl-estradiol-vaginal-ring-added-to-mark-cubans-cost-plus-drugs/
Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid arthritis, Crohn’s disease, hidradenitis suppurativa, and plaque psoriasis (see full indications below). "America’s veterans deserve access to quality medicines at a lower cost. We are proud to support the more than nine million people enrolled in the VA healthcare system through this collaboration, which is a great example of industry and public sector working together,” said Kevin Ali, Organon CEO. “We applaud the VA for its leadership in championing biosimilars and including all three of Organon’s biosimilars available in the US on its formulary." HADLIMA was launched in the US to offer patients a
https://www.organon.com/news/organon-announces-hadlima-adalimumab-bwwd-has-been-exclusively-selected-by-the-us-department-of-veterans-affairs-va-replacing-humira-on-its-national-formulary/
