Viatris向日本厚生劳动省提交了EFFEXOR®用于治疗广泛性焦虑症的补充新药申请-动脉网

Viatris Files Supplemental New Drug Applications to Japan's Ministry of Health, Labor and Welfare for the Approval of EFFEXOR® for the Treatment of Generalized Anxiety Disorder

CISION 等信源发布 2025-04-21 18:59

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Aiming to address a significant unmet need for which no other approved treatment option is available for generalized anxiety disorder patients in

旨在解决广泛性焦虑症患者未被满足的重大需求，目前尚无其他获批的治疗选项可用。

Japan

日本

PITTSBURGH

匹兹堡

，

April 21, 2025

2025年4月21日

/PRNewswire/ --

Viatris Inc.

迈兰制药公司

(Nasdaq:

（纳斯达克：

VTRS

), a global healthcare company, today announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalized anxiety disorder (GAD), an indication for which no other treatment option is currently approved in .

），一家全球医疗保健公司，今天宣布已向厚生劳动省（MHLW）提交了Effexor SR胶囊（盐酸文拉法辛）的申请，这是一种用于治疗成人广泛性焦虑症（GAD）的血清素-去甲肾上腺素再摄取抑制剂（SNRI），目前在该适应症上尚无其他获批的治疗选择。

Japan

日本

。

如

previously announced

之前已宣布

, our Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in

，我们对患有广泛性焦虑症（GAD）的患者进行的第三阶段安慰剂对照、随机、双盲、多中心的文拉法辛研究开展于

Japan

日本

(Study B2411367) achieved its primary objective of superiority of anxiolytic effects of venlafaxine compared to placebo at 8 weeks, based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline (two-sided p-value=0.012). All seven secondary efficacy endpoints as defined by the trial protocol were met.

（研究B2411367）达到了其主要目标，即在8周时，基于汉密尔顿焦虑量表（HAM-A）总分从基线的变化，文拉法辛的抗焦虑效果优于安慰剂（双侧p值=0.012）。根据试验方案定义的全部七个次要疗效终点也都已达成。

These results and results from a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications..

这些结果以及文拉法辛在日本门诊广泛性焦虑症患者长期扩展研究中的结果被作为申请的一部分包含在内。

'The filing of our supplemental New Drug Applications is a key milestone as we move one step closer to bringing the first available treatment option for generalized anxiety disorder to adults in

“我们提交补充新药申请是一个关键的里程碑，因为我们正朝着为成人提供首个广泛性焦虑症治疗选择的目标迈近了一步。

Japan

日本

,' said Viatris Chief R&D Officer

`,Viatris首席研发官说

Philippe Martin

菲利普·马丁

. 'Positive results from our previously announced Phase 3 efficacy and safety studies laid the foundation for our applications with the MHLW. Effexor for GAD is among a number of novel assets we are advancing through our diversified pipeline to address significant unmet needs.'

“我们之前宣布的第三阶段疗效和安全性研究的积极结果为我们向厚生劳动省（MHLW）的申请奠定了基础。Effexor用于治疗广泛性焦虑症（GAD）是我们通过多样化渠道推进的众多创新资产之一，旨在满足显著未被满足的需求。”

Patients with GAD can experience persistent, excessive and uncontrollable anxiety or worry about everyday life activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may impair patients' social, occupational, or other areas of functioning..

患有GAD的患者可能会经历持续、过度且无法控制的对日常活动的焦虑或担忧。其他症状包括难以获得足够的睡眠、肌肉紧张/僵硬、感到坐立不安、易怒或难以集中注意力，这些可能会损害患者的社交、职业或其他功能领域。

在

Japan

日本

, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime.

，世界卫生组织报告称，2.6%的人口在其一生中将患有广泛性焦虑症（GAD）。

A recent study using a screening tool (GAD-7 ≧ 10) reported the prevalence of probable GAD in

一项最近使用筛查工具（GAD-7 ≧ 10）的研究报告了可能患有广泛性焦虑症（GAD）的患病率。

Japan

日本

is 7.6%.

是7.6%。

This data suggests that GAD may be significantly underdiagnosed in

这份数据表明，GAD可能被显著地低估了诊断。

Japan

日本

。

Outside of

在...之外

Japan

日本

, selective serotonin reuptake inhibitors (SSRIs) and SNRIs are recommended as first-line drug therapies for patients diagnosed with GAD. EFFEXOR

，选择性5-羟色胺再摄取抑制剂（SSRIs）和SNRIs被推荐为诊断为广泛性焦虑症（GAD）患者的首选药物治疗。EFFEXOR

is currently approved in

目前已获批准

Japan

日本

for the indication of major depressive disorder in adults. EFFEXOR

用于治疗成人重度抑郁症。EFFEXOR

has also been approved for the indication of GAD in more than 80 countries outside of

也已被批准用于超过80个国家的GAD适应症

Japan

日本

。

References

参考文献

Viatris Announces Positive Top-line Results from Phase 3 Study of EFFEXOR® in Japanese Adults with Generalized Anxiety Disorder (GAD)

辉瑞宣布EFFEXOR®在日本成人广泛性焦虑症（GAD）的3期研究中取得积极的初步结果

Takahashi, Saburo et al., supervisor of translation; II. Diagnostic Criteria and Code 5 Anxiety Disorders/Generalized Anxiety Disorder (p242-246): DSM-5-TR Diagnostic and Statistical Manual of Mental Disorders, Igaku-Shoin

高桥三郎等，翻译监督；II. 诊断标准与编码5 焦虑障碍/广泛性焦虑障碍（第242-246页）：DSM-5-TR 精神障碍诊断与统计手册，医学书院

Stein DJ, Kazdin AE, Ruscio AM, et al. Perceived helpfulness of treatment for generalized anxiety disorder: a World Mental Health Surveys report. BMC Psychiatry. 2021;21(1):392.

Stein DJ, Kazdin AE, Ruscio AM, 等。广义焦虑症治疗的感知帮助性：世界心理健康调查报告。BMC精神病学。2021;21(1):392。

Matsuyama S, Otsubo T, Nomoto K, Higa S, Takashio O. Prevalence of Generalized Anxiety Disorder in

松山 S，大坪 T，野本 K，比嘉 S，高塩 O。广泛性焦虑症的患病率

Japan

日本

: A General Population Survey. Neuropsychiatr Dis Treat. 2024 Jun 26;20:1355-1366. doi: 10.2147/NDT.S456272. PMID: 38947368; PMCID: PMC11214750.

: 一般人群调查。《神经精神疾病与治疗》。2024年6月26日；20:1355-1366。doi: 10.2147/NDT.S456272。PMID: 38947368；PMCID: PMC11214750。

About Generalized Anxiety Disorder (GAD)

关于广泛性焦虑障碍 (GAD)

Generalized Anxiety Disorder (GAD) is a mental health disorder whose central symptom is chronic and uncontrollable 'anxiety' or 'worry' about everyday life events or activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may cause impairment in social, occupational, or other areas of functioning.

广泛性焦虑障碍（GAD）是一种心理健康障碍，其核心症状是对日常生活事件或活动持续且无法控制的“焦虑”或“担忧”。其他症状包括难以获得足够睡眠、肌肉紧张/僵硬、感到不安、易怒或难以集中注意力，这些可能会导致社交、职业或其他功能领域的损害。

In .

在。

Japan

日本

, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime. A recent study using a screening tool (GAD-7 ≧ 10) reported the prevalence of probable GAD in

，世界卫生组织报告称，2.6%的人口在其一生中将患有广泛性焦虑症（GAD）。一项最近使用筛查工具（GAD-7 ≧ 10）的研究报告了可能患有广泛性焦虑症的患病率。

Japan

日本

is 7.6%.

是7.6%。

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的每个阶段过上更健康生活的能力，我们大规模提供药品，目前每年向全球约10亿患者供应高质量药品，并覆盖生命的所有时刻，从出生到生命结束，从急性病到慢性病。

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, .

凭借我们异常广泛且多样化的药品组合、独一无二的全球供应链（旨在无论何时何地，都能为更多有需要的人提供帮助），以及应对一些世界最持久健康挑战的科学专业知识，“可及性”在Viatris具有深远的意义。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

. 了解更多，请访问

viatris.com

and

和

investor.viatris.com

投资者.viatris.com

, and connect with us on

，与我们保持联系并在

领英

，

Instagram

，

YouTube

and

和

(formerly Twitter).

（前身为Twitter）。

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 receipt or timing of regulatory approvals; the outcome of clinical trials; the filing of our supplemental New Drug Applications is a key milestone as we move one step closer to bringing the first available treatment option for generalized anxiety disorder to adults in .

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有关收到或获得监管批准的时间；临床试验的结果；我们提交补充新药申请是迈向为成人提供首个广泛性焦虑症治疗选择的重要里程碑。

Japan

日本

; and Effexor for GAD is among a number of novel assets we are advancing through our diversified pipeline to address significant unmet needs. 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.

；Effexor用于治疗广泛性焦虑障碍（GAD）是我们通过多样化渠道推进的众多新型资产之一，旨在满足显著未被满足的需求。由于前瞻性陈述本身包含风险和不确定性，实际未来结果可能与这些前瞻性陈述所表达或暗示的有重大差异。

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. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, tariffs and trade policies, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ('SEC').

可能导致或促成此类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定；我们遵守适用法律法规的能力；美国和国外医疗和药品法律法规的变化；任何监管、法律或其他障碍，阻碍Viatris将新产品推向市场的能力；Viatris或其合作伙伴开发、制造和推广产品的能力；任何正在进行的法律程序的范围、时间和结果，以及任何此类程序对Viatris的影响；Viatris未能实现预期或目标的未来财务和运营绩效及结果；与国际业务相关的风险；第三方关系的变化；Viatris或其合作伙伴的客户和供应商关系及客户购买模式变化的影响；竞争的影响；Viatris或其合作伙伴经济和财务状况的变化；管理层无法控制的不确定性和事项，包括但不限于总体政治和经济状况、关税和贸易政策、通货膨胀率及全球汇率；以及Viatris向证券交易委员会（“SEC”）提交文件中描述的其他风险。

Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for pu.

Viatris 常规利用其网站以广泛、非排他性的方式向公众披露重要信息。

SOURCE Viatris Inc.

来源：辉瑞公司

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