JERSEY CITY, N.J.--(BUSINESS WIRE) December 16, 2024 -- 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) has approved Vtama® (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 Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.“With the FDA’s 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,” said Kevin Ali, Organon’s Chief Executive Officer.

新泽西州泽西市--（商业新闻）2024年12月16日--Organon（纽约证券交易所代码：OGN）是一家致力于改善女性终生健康的全球医疗保健公司，今天宣布，美国食品和药物管理局（FDA）已批准1%芳基烃受体激动剂Vtama®（tapinarof）乳膏，用于成人和2岁及以上儿科患者特应性皮炎（AD）局部治疗的额外适应症。1 Organon在2025年3月12日延长目标行动日期（PDUFA）之前获得FDA批准。“FDA批准Vtama乳膏治疗特应性皮炎Organon首席执行官凯文·阿里（KevinAli）说：“对于2岁以下的成年人和儿童来说，现在有一种疗法可以提供强大的皮肤清除能力，没有标签警告或预防措施、禁忌症，也不限制使用时间或受影响的体表面积百分比。”。

“Introducing this new first-in-class therapy for AD patients reaffirms Organon’s commitment to addressing areas of high unmet need.”In 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 <0.0001).

“为AD患者引入这种新的一流疗法，重申了Organon对解决高度未满足需求领域的承诺。”在ADORING pivotal研究中，Vtama乳膏显示，在2岁以下的中度至重度AD患者中，1%的患者在经过验证的AD研究者全球评估（vIGA AD）中，在第8周达到清晰（0）或几乎清晰（1）评分且从基线至少改善2级的患者比例与媒介物相比有统计学显着差异。45.4%对ADORING 1的患者为13.9%，46.4%对ADORING 2的患者为18.0%（均P＜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) .

在所有次要终点接受Vtama乳膏治疗的患者与接受载体治疗的患者之间的差异具有统计学意义，包括湿疹面积和严重程度指数（EASI）评分改善至少75%（EASI75）。