Viatris宣布针对育龄妇女的低剂量避孕贴片XULANE LO™的三期研究取得积极结果-动脉网

Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential

CISION 等信源发布 2025-05-08 18:45

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Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints

使用XULANE LO低雌激素剂量治疗达到了主要和所有次要的疗效与安全终点

Results Demonstrated Potential Best-In-Class Patch Performance

结果表明，性能潜力最佳的贴片表现亮眼。

New Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025

预计将在2025年下半年向美国FDA提交新药申请。

PITTSBURGH

匹兹堡

，

May 8, 2025

2025年5月8日

/PRNewswire/ --

Viatris Inc.

迈兰制药公司

(Nasdaq:

（纳斯达克：

VTRS

a global healthcare company, today announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential.

一家全球医疗保健公司今天宣布了其三期临床研究（NCT05139121）的积极结果，该研究评估了在育龄妇女中使用含150微克norelgestromin和17.5微克乙炔雌二醇的低剂量每周一次XULANE LO透皮贴片的避孕效果和安全性。

The study evaluated women of childbearing potential (N=1,272) for up to 13 cycles (12,591 safety evaluable cycles and 9,105 efficacy evaluable cycles) across 81 investigative sites throughout the U.S., .

该研究在美国81个试验点评估了1272名育龄妇女，最多达13个周期（12591个安全性可评估周期和9105个有效性可评估周期）。

Puerto Rico

波多黎各

and

和

Canada

加拿大

。

In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile. In particular:

在这项研究中，XULANE LO 展现了良好的疗效和安全性，没有发现新的安全隐患，同时具有潜在的同类最佳贴片性能。特别是：

With a Pearl Index (PI) of 4.14, the study demonstrated contraceptive efficacy. This primary efficacy endpoint was measured in eligible women aged 16 to 35 with a body mass index <30 mg/m

研究表明，珍珠指数（PI）为4.14时具有避孕效果。这一主要疗效终点是在16至35岁、体重指数<30 mg/m的符合条件的女性中测量的。

and at least one efficacy evaluable cycle. Additionally, the cumulative probability of pregnancy over 13 cycles was 3.7%.

并且至少有一个疗效可评估的周期。此外，13个周期内怀孕的累积概率为3.7%。

A favorable safety and tolerability profile was observed with most treatment emergent adverse events (TEAEs) reported as mild-to-moderate. Favorable cycle control was also observed with generally low unscheduled bleeding and spotting events.

观察到良好的安全性和耐受性特征，大多数治疗中出现的不良事件（TEAEs）为轻至中度。还观察到良好的周期控制，通常具有较低的非计划性出血和点滴出血事件。

The study demonstrated a potential best-in-class patch adhesion profile with very few patches (1.3%) completely detaching over the seven-day wearing period and <1% of subjects reporting severe local application site reactions.

研究显示，在为期七天的佩戴过程中，仅有极少数贴片（1.3%）完全脱落，并且不到1%的受试者报告了严重局部应用部位反应，展现出潜在的最佳贴片粘附性能。

'We are pleased with the profile our investigational XULANE LO low dose patch demonstrated in this Phase 3 study,' said Viatris Chief R&D Officer

“我们对我们的研究性XULANE LO低剂量贴片在这项III期研究中展示的特性感到满意，”Viatris首席研发官表示。

Philippe Martin

菲利普·马丁

. 'The data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance.'

“数据增强了我们对XULANE LO潜力的信心，它能够满足女性对于一种可逆避孕方法的重要需求，这种方法通过每周一次的贴片提供较低剂量的雌激素，并具备潜在的最佳粘附性能。”

The Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2025.

公司计划在2025年下半年向美国食品药品监督管理局 (FDA) 提交新药申请。

About the Phase 3 Study Design (NCT05139121)

关于第 3 阶段研究设计 (NCT05139121)

The multicenter, open-label, single-arm study, evaluated the contraceptive efficacy of investigational XULANE LO low dose patch when used over thirteen 28-day cycles in 1,272 healthy, post-menarcheal, pre-menopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age..

这项多中心、开放标签、单臂研究评估了在1,272名健康、初潮后、绝经前、异性性活跃、具有生育能力且年满16岁的女性受试者中，使用XULANE LO低剂量贴片十三个28天周期的避孕效果。

About Viatris

关于Viatris

Viatris Inc.

迈兰制药公司

(Nasdaq:

（纳斯达克：

VTRS

) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

）是一家全球医疗保健公司，独特地定位为弥合仿制药和品牌药之间的传统鸿沟，结合两者的优势，更全面地应对全球医疗保健需求。我们的使命是赋予全世界人民在生命每个阶段过上更健康生活的能力，目前我们大规模提供高品质药物，每年向全球约10亿患者供应药品，并贯穿生命的每个时刻，从出生到生命终结，从急性病到慢性疾病。

With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, .

凭借我们异常广泛和多样化的药品组合、独一无二的全球供应链（旨在无论何时何地都能覆盖更多有需要的人），以及应对世界上一些最持久健康挑战的科学专业知识，"可及性"在Viatris具有深刻的含义。我们总部位于美国，并在匹兹堡、上海和海得拉巴设有全球中心。

India

印度

. Learn more at

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viatris.com

and

和

investor.viatris.com

, and connect with us on

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Forward-Looking Statements

前瞻性声明

This press release includes statements that constitute 'forward-looking statements.' These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding the outcomes of clinical trials; NDA submission to FDA anticipated in the second half of 2025; XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile; and the data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance.

本新闻稿包含构成“前瞻性声明”的陈述。这些声明是根据1995年《私人证券诉讼改革法案》的安全港条款作出的。此类前瞻性声明可能包括关于临床试验结果的声明；预计在2025年下半年向FDA提交NDA；XULANE LO展示了良好的有效性和安全性，未发现新的安全问题，并且具有潜在的最佳贴片性能；数据进一步增强了我们对XULANE LO潜力的信心，它能够满足女性寻求一种每周使用、低雌激素剂量、具有潜在最佳粘附性能的可逆避孕方法的重要需求。

Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S.

由于前瞻性陈述本身涉及风险和不确定性，实际的未来结果可能与这些前瞻性陈述所表达或暗示的内容有重大差异。可能导致或促成这种差异的因素包括但不限于：医疗和药品监管机构的行动和决策；我们遵守适用法律法规的能力；美国医疗和药品法律法规的变化。

and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceeding.

以及国外；任何对Viatris将新产品推向市场能力的监管、法律或其他障碍；在研产品虽获监管批准，但可能无法达到预期的市场接受度、疗效或安全性；由于监管优先事项的变化及卫生机构人员减少，审查、回应和批准时间延长；Viatris及其合作伙伴开发、生产及商业化产品的能力；任何正在进行的法律程序的范围、时间和结果。

SOURCE Viatris Inc.

来源：Viatris Inc.

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