- \n
- EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on VTAMA cream achieved vIGA-AD\u2122 treatment success at Week 8 versus 18% of patients on vehicle.<\/i><\/li>\n
- 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.<\/i><\/li>\n
- RAPID ITCH RELIEF: Itch improvement as early as 24 hours after first application of VTAMA cream was reported by patients and caregivers.<\/i><\/li>\n
- SAFE AND TOLERABLE: VTAMA cream demonstrated a favorable and consistentsafety 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.<\/i><\/li>\n<\/ul>\n
JERSEY CITY, N.J.–(BUSINESS WIRE<\/a>)–
\nOrganon (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) has approved VTAMA\u00ae<\/sup> (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.1<\/sup> Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.<\/p>\n\n\u201cWith the FDA\u2019s approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected,\u201d said Kevin Ali, Organon\u2019s Chief Executive Officer. \u201cIntroducing this new first-in-class therapy for AD patients reaffirms Organon\u2019s commitment to addressing areas of high unmet need.\u201d<\/p>\n
\nIn the ADORING pivotal studies, VTAMA cream, 1% demonstrated, in moderate to severe patients as young as 2 years old with AD, a statistically significant difference versus vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) 45.4% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2 (both P<\/i><0.0001). The difference between patients who received VTAMA cream and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 75% (EASI75) from baseline at Week 8 and achievement of a \u22654-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients \u226512 years of age. The most common adverse reactions (incidence \u22651%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%).<\/p>\n
\nADORING 3, a 48-week open-label, LTE study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were VTAMA cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria.<\/p>\n
\nIn ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD\u22651) were treated with VTAMA cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with VTAMA cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD\u22652) were re-treated with VTAMA cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8.<\/p>\n
\n\u201cVTAMA cream approval in AD is important because it can be prescribed for children as young as 2 years old. VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease,\u201d said Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children\u2019s Memorial Hermann Hospital and lead investigator for the ADORING program. \u201cMoreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition\u2019s most prevalent symptoms with use of VTAMA cream.\u201d<\/p>\n
\nIn May 2022, the FDA approved VTAMA\u00ae<\/sup> (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults, making it the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis with no label warnings or precautions, contraindications, restrictions on duration of use, or percentage of body surface area affected.<\/p>\n
\nFor more information about VTAMA (tapinarof) cream, 1%, visit www.VTAMA.com<\/a>.<\/p>\n
IMPORTANT SAFETY INFORMATION<\/b><\/p>\n
Indications:<\/b> VTAMA\u00ae<\/sup> (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for:<\/p>\n
- \n
- \nthe topical treatment of plaque psoriasis in adults.<\/p>\n<\/li>\n
- \nthe topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.<\/p>\n<\/li>\n<\/ul>\n
Adverse Events:<\/b> In plaque psoriasis, the most common adverse reactions (incidence \u22651%) 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).<\/p>\n
Adverse Events:<\/b> In atopic dermatitis, the most common adverse reactions (incidence \u22651%) 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.<\/p>\n
\nYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov\/medwatch<\/a> or call 1-800-FDA-1088.<\/p>\n
\nSee full Prescribing Information and Patient Information.<\/a><\/p>\n
About Atopic Dermatitis<\/b><\/p>\n
\nAtopic dermatitis (AD), commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. 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. Itching is an especially bothersome symptom for those with AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.<\/p>\n
About Organon<\/b><\/p>\n
Organon<\/a> is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon\u2019s diverse portfolio offers more than 60 medicines and products in women\u2019s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon\u2019s current products, the company invests in innovative solutions and research to drive future growth opportunities in women\u2019s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon\u2019s scale and agile presence in fast growing international markets.<\/p>\n
\nOrganon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.<\/p>\n
\nFor more information, visit http:\/\/www.organon.com<\/a> and connect with us on LinkedIn<\/a>, Instagram<\/a>, X (formerly known as Twitter)<\/a> and Facebook<\/a>.<\/p>\n
\nvIGA-AD is the trademark of Eli Lilly and Co.<\/p>\n
Cautionary Note Regarding Forward-Looking Statements<\/b><\/p>\n
\nExcept for historical information, this press release includes \u201cforward-looking statements\u201d within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management\u2019s expectations about the potential safety, effectiveness, tolerability, uses, and market for VTAMA cream. Forward-looking statements may be identified by words such as \u201cpursuing,\u201d \u201copportunities,\u201d \u201cfuture,\u201d \u201cpotential,\u201d \u201cpotentially,\u201d \u201cexpected,\u201d \u201cexpects,\u201d \u201cwill\u201d or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon\u2019s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or additional risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of the FDA approval described above; weakening of economic conditions that could adversely affect the level of demand for VTAMA; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon\u2019s product development and commercialization plans; an inability to adapt to the industry-wide trend toward highly discounted channels; expanded brand and class competition in the markets in which Organon operates; and governmental initiatives that adversely impact Organon\u2019s marketing activities. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon\u2019s filings with the Securities and Exchange Commission (SEC), including Organon\u2019s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC\u2019s Internet site www.sec.gov<\/a>. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.<\/p>\n
1<\/sup> VTAMA label.<\/p>\n
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\nFelicia Bisaro
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(646) 703-1807<\/p>\n\nKarissa Peer
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\nJennifer Halchak
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(201) 275-2711<\/p>\nKEYWORDS:<\/b> New Jersey United States North America<\/p>\n
INDUSTRY KEYWORDS:<\/b> Research Women FDA Clinical Trials Biotechnology Health Consumer Pharmaceutical Science<\/p>\n
- 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.<\/i><\/li>\n
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