艾玛乌斯生命科学公司获得FDA批准，用于Endari®标签增强-动脉网

Emmaus Life Sciences Receives FDA Approval for Endari® Label Enhancements

CISION 等信源发布 2025-06-26 21:30

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可切换为仅中文

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Changes Based on Additional Pharmacokinetics Data

基于额外药代动力学数据的变更

TORRANCE, Calif.

加利福尼亚州托伦斯市

，

June 26, 2025

2025年6月26日

/PRNewswire/ --

Emmaus

厄玛乌

Life Sciences, Inc.

生命科学公司

(OTCQB:

EMMA

爱玛

), a leader in sickle cell disease treatment, announced today that it has received Food and Drug Administration (FDA) approval for changes to the labelling of Endari® to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus. The additional information provides a more comprehensive characterization of Endari, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari with or without food.

），一家在镰状细胞病治疗领域的领导者，今天宣布它已获得美国食品药品监督管理局（FDA）批准，对Endari®的标签进行修改，以反映由Emmaus提交的上市后药代动力学研究数据得出的额外处方信息。新增的信息对Endari进行了更全面的描述，包括按体重确认剂量、每日两次给药不会产生不良积累，以及无论是否与食物同服均可给予Endari的能力。

Endari® is approved in the U.S. and elsewhere to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older..

Endari® 已在美国及其他地区获批，用于减少五岁及以上成人和儿童患者的镰状细胞病急性并发症。

About Emmaus Life Sciences

关于以马忤斯生命科学公司

Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development, marketing, and sale of innovative treatments and therapies, including those for rare and orphan diseases. For more information, please visit

Emmaus Life Sciences, Inc. 是一家商业阶段的生物制药公司，专注于发现、开发、营销和销售创新治疗和疗法，包括针对罕见病和孤儿病的治疗。欲了解更多信息，请访问

www.emmausmedical.com

。

About Endari®

关于Endari®

(prescription-grade L-glutamine oral powder)

（处方级L-谷氨酰胺口服粉）

Indication - Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients aged five years and older.

适应症 - Endari 适用于减少五岁及以上成人和儿童患者的镰状细胞病急性并发症。

Important Safety Information

重要安全信息

The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.

临床研究中最常见的不良反应（发生率 >10%）包括便秘、恶心、头痛、腹痛、咳嗽、四肢疼痛、背痛和胸痛。

Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.

导致治疗中断的不良反应包括一例脾功能亢进、一例腹痛、一例消化不良、一例灼烧感和一例潮热。

The safety and efficacy of Endari® in pediatric patients with sickle cell disease younger than five years of age has not been established.

Endari® 在五岁以下镰状细胞病儿科患者中的安全性和有效性尚未确定。

For more information, please see full Prescribing Information of Endari® at:

有关更多信息，请参阅Endari®的完整处方信息：

www.ENDARIrx.com/PI

。

About Sickle Cell Disease

关于镰状细胞病

There are approximately 100,000 people living with sickle cell disease (SCD) in

在美国，大约有十万人患有镰状细胞病（SCD），

the United States

美国

and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in

在全球范围内还有数百万人。镰状细胞基因存在于每个种族群体中，而不仅仅是在非洲裔人群中；并且在

the United States

美国

an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.

据估计，每365名非洲裔美国人和每16,300名西班牙裔美国人中就有一人出生时患有镰状细胞病。

The genetic mutation responsible for SCD causes an individual's red blood cells to distort into a 'C' or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels.

导致镰状细胞病的基因突变使个体的红细胞扭曲成“C”形或镰刀形，降低了它们在全身运输氧气的能力。这些镰状红细胞迅速分解，变得非常粘稠，并且容易聚集在一起，导致它们卡在血管中并造成损害。

The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death..

结果是远端器官的血流量减少，这会导致令人虚弱的疼痛、组织和器官损伤以及早逝的生理症状。

Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention,

来源：镰状细胞病的数据与统计 – 国家出生缺陷和发育障碍中心，疾病控制与预防中心，

December 2020

2020年12月

。

Source: Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action -- National Academy of Sciences Press, 2020.

来源：《解决镰状细胞病的战略计划和行动蓝图》——美国国家科学院出版社，2020年。

Forward-looking Statements

前瞻性声明

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the safety of Endari. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risks and other factors previously disclosed in the company's reports filed with the Securities and Exchange Commission, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and Emmaus assumes no duty to update them, except as may be required by law. .

本新闻稿包含根据经修订的 1995 年《私人证券诉讼改革法案》的安全港条款作出的前瞻性声明，包括关于 Endari 安全性的声明。这些前瞻性声明受制于众多假设、风险和不确定性，这些因素会随着时间而变化，包括公司之前在向证券交易委员会提交的报告中披露的风险及其他因素，实际结果可能会有重大差异。此类前瞻性声明仅在其作出之日有效，Emmaus 概不承担更新这些声明的责任，除非法律另有要求。

Company Contact:

公司联系人：

Emmaus Life Sciences, Inc.

艾玛乌斯生命科学公司

Investor Relations

投资者关系

IR@emmauslifesciences.com

SOURCE Emmaus Life Sciences, Inc.

来源：Emmaus Life Sciences, Inc.

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