JERSEY CITY, N.J., May 3, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of an abstract in amyotrophic lateral sclerosis (ALS) at the Professional Society for Health Economics and Outcomes Research (ISPOR) 2024 Annual Meeting, being held in Atlanta, Ga., May 5-8, 2024.

新泽西州泽西市，2024年5月3日/PRNewswire/--三菱田边制药美国公司（MTPA）今天宣布，在2024年5月5日至8日于佐治亚州亚特兰大举行的2024年健康经济与成果研究专业学会（ISPOR）年会上，提交了肌萎缩侧索硬化症（ALS）摘要。

The presentation will include updated results from an ongoing analysis of real-world data from RADICAVA ORS® (edaravone)-treated people living with ALS..

该演讲将包括对来自RADICAVA ORS®（依达拉奉）治疗的ALS患者的真实数据进行持续分析的最新结果。。

'As MTPA continues to build upon our real-world data, we look forward to sharing results from an ongoing analysis of RADICAVA ORS at the ISPOR 2024 Annual Meeting,' said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. 'We hope these findings provide helpful insights for healthcare providers to support clinical decisions in an effort to improve care for people living with ALS.'.

MTPA负责医疗事务的副总裁Gustavo A.Suarez Zambrano医学博士说：“随着MTPA继续以我们的真实数据为基础，我们期待在ISPOR 2024年会上分享正在进行的RADICAVA ORS分析的结果。”我们希望这些发现为医疗保健提供者提供有用的见解，以支持临床决策，从而改善对ALS患者的护理。”。

The preliminary analysis included people living with ALS who were continuously enrolled in Optum's de-identified Clinformatics® Data Mart (CDM) from June 15, 2022, through March 31, 2023. Individuals were divided into two groups: Group 1 initially received intravenous (IV) RADICAVA® (edaravone) and switched to RADICAVA ORS, and Group 2 was RADICAVA-naïve and received RADICAVA ORS.

初步分析包括从2022年6月15日至2023年3月31日持续参加Optum取消识别的Clinformatics®数据集市（CDM）的ALS患者。将个体分为两组：第一组最初接受静脉注射（IV）RADICAVA®（依达拉奉）并改用RADICAVA ORS，第二组未接受RADICAVA ORS并接受RADICAVA ORS。

The ongoing analysis evaluates patient demographics, treatment duration, and progression milestones up to RADICAVA ORS first dosing date..

正在进行的分析评估了患者的人口统计学特征，治疗持续时间和进展里程碑，直到RADICAVA ORS首次给药日期。。

A Preliminary Analysis of Oral Edaravone-Treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Polina Da Silva, MTPA) Poster Session #4 (CO151): 3:30 – 6:30 p.m. EST, May 7

对美国行政索赔数据库（Polina Da Silva，MTPA）海报会议#4（CO151）中登记的口服依达拉奉治疗的肌萎缩侧索硬化症患者的初步分析：美国东部标准时间下午3:30–6:30，5月7日

About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation.

关于RADICAVA®（依达拉奉）和RADICAVA ORS®（依达拉奉），美国食品和药物管理局（FDA）于2017年5月5日批准了RADICAVA®（依达拉奉），并于2022年5月12日批准了口服制剂RADICAVA ORS®（依达拉奉），用于治疗肌萎缩侧索硬化症（ALS）。2024年，FDA基于创新口服制剂对患者护理的主要贡献，认可了具有孤儿药排他性的RADICAVA ORS。

RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period.

RADICAVA通过静脉（IV）输注以28天的周期给药。每服用60毫克需要60分钟。对于初始周期，治疗连续14天每天输注，然后是两周的无药期。此后的所有周期在14天内每天输注10天，然后是两周的无药期。

RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting.

RADICAVA ORS连续14天每天服用，随后在初始治疗周期中有14天的无药期。对于随后的治疗周期，RADICAVA ORS在14天内服用10天，然后服用14天的无药期。应在禁食过夜后的早晨服用RADICAVA ORS。

Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1.

患者服用RADICAVA ORS后一小时内不应进食或饮用（水除外）。

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea.

依达拉奉是由三菱田边制药公司（MTPC）为ALS发现和开发的，并由三菱田边制药美国公司（MTPA）在美国商业化。MTPC集团公司于2001年开始通过13年的迭代临床平台研究ALS。2015年，依达拉奉被批准为RADICUT®，用于治疗日本和韩国的ALS。

Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022.

随后在加拿大（2018年10月）、瑞士（2019年1月）、印度尼西亚（2020年7月）、泰国（2021年4月）、马来西亚（2021年12月）和巴西（2024年2月）授予了营销授权。加拿大（2022年11月）和瑞士（2023年5月）批准了RADICAVA®口服混悬液的上市许可，日本于2022年12月批准了2.1%的RADICUT®口服混悬液。

To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 14,600 people with ALS, with over 1.8-million days of therapy, and have been prescribed by over 2,300 HCPs.2-4.

迄今为止，在美国，RADICAVA和RADICAVA ORS已被用于治疗14600多名ALS患者，治疗时间超过180万天，并已被超过2300名HCPs.2-4开出处方。

IMPORTANT SAFETY INFORMATION

重要安全信息

Hypersensitivity Reactions RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA..

过敏反应RADICAVA（依达拉奉）和RADICAVA ORS（依达拉奉）禁用于对依达拉奉或本产品的任何非活性成分有过敏史的患者。RADICAVA发生了超敏反应（发红，风团和多形红斑）和过敏反应（荨麻疹，血压下降和呼吸困难）。。

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

应仔细监测患者的超敏反应。如果发生超敏反应，停用RADICAVA或RADICAVA ORS，按照标准护理进行治疗，并监测直至病情消退。

Sulfite Allergic Reactions RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people..

亚硫酸盐过敏反应RADICAVA和RADICAVA ORS含有亚硫酸氢钠，亚硫酸氢钠可能引起过敏性反应，包括过敏症状和易感人群的危及生命或较轻的哮喘发作。一般人群中亚硫酸盐敏感性的总体患病率尚不清楚，但在哮喘患者中发生频率更高。。

Adverse Reactions The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

不良反应RADICAVA治疗患者报告的最常见不良反应（≥10%）是挫伤（15%），步态障碍（13%）和头痛（10%）。在一项开放标签研究中，7.6%接受放射治疗的患者也观察到疲劳。

Pregnancy Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.

怀孕根据动物数据，RADICAVA和RADICAVA ORS可能会导致胎儿伤害。

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要报告疑似不良反应或产品投诉，请致电1-888-292-0058联系三菱田边制药美国公司。您也可以通过1-800-FDA-1088或www.FDA.gov/medwatch向FDA报告疑似不良反应。

INDICATION RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

适应症RADICAVA和RADICAVA ORS适用于治疗肌萎缩侧索硬化症（ALS）。

For more information, including full Prescribing Information, please visit www.RADICAVA.com.

有关更多信息，包括完整的处方信息，请访问www.RADICAVA.com。

About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America.

关于位于新泽西州泽西市的三菱田边制药美国公司，三菱田边制药美国公司（MTPA）是三菱田边制药公司（MTPC）的全资子公司。它由MTPC成立，旨在开发和推进我们的管道，并在北美将经批准的药品商业化。

For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn..

有关更多信息，请访问www.mt-pharma-america.com或在X（以前的Twitter）、Facebook和LinkedIn上关注我们。。

About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry.

关于三菱田边制药公司三菱田边制药公司（MTPC）是三菱化学集团（MCG）的制药子公司，成立于1678年，是世界上最古老的制药公司之一。MTPC总部位于日本制药业的发源地大阪市的Doshomachi。

MCG has positioned health care as its strategic focus in its management policy, 'Forging the future'. MTPC sets the MISSION of 'Creating hope for all facing illness'. To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on 'precision medicine' to provide drugs with high treatment satisfaction and additionally working to develop 'around the pill solutions' to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis.

MCG已将医疗保健定位为其管理政策“打造未来”的战略重点。MTPC设定了“为所有面临疾病的人创造希望”的使命。为此，MTPC正在研究中枢神经系统、免疫炎症、糖尿病和肾脏以及癌症等疾病领域。MTPC专注于“精准医学”，以提供高治疗满意度的药物，并致力于开发“围绕药丸的解决方案”，以解决基于治疗医学的特定患者问题，包括预防疾病，症状前疾病护理，预防恶化和预后。

For more information, go to https://www.mt-pharma.co.jp/e/..

有关更多信息，请访问https://www.mt-pharma.co.jp/e/..

Media inquiries: Media_MTPA@mt-pharma-us.com

媒体查询：Media_MTPA@mt-pharma-us.com

1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2 Data on file. Mitsubishi Tanabe Pharma America, Inc. 3 Data on file. Mitsubishi Tanabe Pharma America, Inc. 4 Data on file. Mitsubishi Tanabe Pharma America, Inc.

1 RADICAVA和RADICAVA ORS规定信息。新泽西州泽西市：三菱田边制药美国公司。；2022年2月存档数据。Mitsubishi Tanabe Pharma America，Inc.3存档数据。Mitsubishi Tanabe Pharma America，Inc.4存档数据。三菱田边制药美国公司。

SOURCE Mitsubishi Tanabe Pharma America

来源：三菱田边制药（美国）