Mitsubishi Tanabe Pharma America to Present RADICAVA ORS (Edaravone) Real-World Data at the Professional Society for Health Economics and Outcomes Research 2024 Annual Meeting
Mitsubishi Tanabe Pharma America to Present RADICAVA ORS (Edaravone) Real-World Data at the Professional Society for Health Economics and Outcomes Research 2024 Annual Meeting
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. The presentation will include updated results from an ongoing analysis of real-world data from RADICAVA ORS(edaravone)-treated people living with ALS.
新泽西州泽西城，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日在乔治亚州亚特兰大举行的健康经济学与结果研究专业协会（ISPOR）2024年年会上发表肌萎缩侧索硬化症（ALS）摘要。该演示将包括对来自RADICAVA ORS的真实世界数据进行持续分析的最新结果（依达拉冯）治疗了肌萎缩性侧索硬化症患者。
"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医学事务副总裁古斯塔沃·苏亚雷斯·赞布拉诺医学博士表示：“随着MTPA继续建立在我们的现实世界数据基础上，我们期待在ISPOR 2024年年会上分享对RADICAVA ORS的持续分析结果。”“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，努力改善对肌萎缩性侧索硬化症患者的护理。”
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. The ongoing analysis evaluates patient demographics, treatment duration, and progression milestones up to RADICAVA ORS first dosing date.
初步分析包括持续报名参加Optum已去识别的Clinformatics的肌萎缩性侧索硬化症患者 数据集市 (CDM) 从 2022 年 6 月 15 日到 2023 年 3 月 31 日。个体分为两组：第 1 组最初接受静脉注射 (IV) RADICAVA （依达拉冯）并改用 RADICAVA ORS，第 2 组是 Radicava-naiève，接受了 RADICAVA ORS。正在进行的分析评估了RADICAVA ORS首次给药日期之前的患者人口统计、治疗持续时间和进展里程碑。
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A Preliminary Analysis of Oral Edaravone-Treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database
(Malgorzata Ciepielewska, MS, MTPA)
Poster Session #3 (CO151): 10:30 a.m. – 1:30 p.m. EST, May 7
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对加入美国行政索赔数据库的经口服依达拉文治疗的肌萎缩性侧索硬化症患者的初步分析
(MTPA Malgorzata Ciepeelewska，MTPA)
海报会议 #3 (CO151)：美国东部标准时间上午 10:30 — 下午 1:30，5 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. 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 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. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1
关于 RADICAVA （依达拉冯）和 RADICAVA ORS （依达拉冯）
美国食品药品监督管理局 (FDA) 批准了 RADICAVA （依达拉冯）于 2017 年 5 月 5 日发布，口服制剂 RADICAVA ORS （依达拉丰）将于2022年5月12日上市，用于治疗肌萎缩性侧索硬化症（ALS）。2024年，基于RADICAVA ORS对患者护理的重大贡献，美国食品药品管理局认可了具有孤儿药独家经营权的RADICAVA ORS。RADICAVA 以 28 天为周期通过静脉（IV）输注给药。每60毫克剂量需要60分钟才能接种。在初始周期中，连续14天每天注射治疗，然后是为期两周的无药期。此后的所有周期在14天内每天注射10天，然后是为期两周的无毒期。RADICAVA ORS 每天连续服用 14 天，然后在初始治疗周期中服用 14 天的无药期。在随后的治疗周期中，RADICAVA ORS在14天内服用10天，然后在14天无药期内服用。RADICAVA ORS 应在隔夜禁食后的早上服用。患者在服用RADICAVA ORS后一小时内不应进食或饮水（水除外）。1
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. 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. 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
Edaravone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集团各公司于2001年通过迭代临床平台开始研究肌萎缩性侧索硬化症，历时13年。2015 年，依达拉丰被批准为 RADICUT 用于在日本和韩国治疗肌萎缩性侧索硬化症。随后，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）获得了上市许可。RADICAVA 的上市许可 加拿大（2022年11月）和瑞士（2023年5月）和RADICUT批准了口服停药 2022年12月，2.1％的口服混悬液在日本获得监管部门的批准。迄今为止，在美国，RADICAVA和RADICAVA ORS已被用于治疗超过14,600名肌萎缩性侧索硬化症患者，治疗天数超过180万天，超过2300名HCP已开处方。2-4
IMPORTANT SAFETY INFORMATION
重要的安全信息
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.
超敏反应
RADICAVA（依达拉酮）和 RADICAVA ORS（依达拉酮）对依达拉奉或本品任何非活性成分有过敏史的患者禁用。RADICAVA 出现过敏反应（发红、丘疹和多形红斑）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.
应仔细监测患者是否有超敏反应。如果出现超敏反应，请停用 RADICAVA 或 RADICAVA ORS，按照标准护理进行治疗，并进行监测直至病情缓解。
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，这种亚硫酸盐可能会引起过敏型反应，包括过敏症状和易感人群危及生命或不太严重的哮喘发作。普通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的频率更高。
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
在接受Radicava治疗的患者中报告的最常见的不良反应（≥ 10%）是挫伤（15%）、步态障碍（13%）和头痛（10%）。在一项开放标签研究中，在接受RADICAVA ORS治疗的患者中，有7.6％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可能会对胎儿造成伤害。
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 .
要报告疑似不良反应或产品投诉，请致电1-888-292-0058与三菱田边制药美国公司联系。您也可以通过 1-800-FDA-1088 或... 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).
指示
RADICAVA 和 RADICAVA ORS 适用于治疗肌萎缩性侧索硬化症 (ALS)。
For more information, including full Prescribing Information, please visit .
欲了解更多信息，包括完整的处方信息，请访问。
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. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn.
关于三菱田边制药美国有限公司
三菱田边制药美国公司（MTPA）总部位于新泽西州泽西城，是三菱田边制药公司（MTPC）的全资子公司。它由MTPC建立，旨在开发和推进我们的产品线，并在北美实现经批准的药品的商业化。欲了解更多信息，请在 X（前身为推特）、脸书和领英上访问或关注我们。
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. 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. For more information, go to
关于三菱田边制药株式会社
三菱化学集团（MCG）的制药部门三菱田边制药公司（MTPC）是世界上最古老的制药公司之一，成立于1678年。MTPC总部位于日本制药业的发源地大阪道修町。MCG在其管理政策 “创造未来” 中将医疗保健定位为其战略重点。MTPC的使命是 “为所有面临疾病的人创造希望”。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”，以提供治疗满意度高的药物，此外还致力于开发 “药丸周围的解决方案”，以解决基于治疗医学的特定患者问题，包括疾病预防、症状前疾病护理、预防恶化和预后。欲了解更多信息，请访问
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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 处方信息。新泽西州泽西城：三菱田边制药美国有限公司；2022年。
2 存档的数据。三菱田边制药美国有限公司
3 存档的数据。三菱田边制药美国有限公司
4 存档的数据。三菱田边制药美国有限公司
SOURCE Mitsubishi Tanabe Pharma America
来源：美国田边三菱制药公司
译文内容由第三方软件翻译。