Mitsubishi Tanabe Pharma America, Inc. (MTPA) Stands With the ALS Community
Mitsubishi Tanabe Pharma America, Inc. (MTPA) Stands With the ALS Community
JERSEY CITY, N.J., May 23, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) is aware of recent external challenges facing the amyotrophic lateral sclerosis (ALS) treatment landscape. We know firsthand the great need for ALS treatments and when there is a setback for one of us, the entire community is affected.
新澤西州澤西城，2024年5月23日 /PRNewswire/ — 三菱田邊製藥美國公司（MTPA）意識到肌萎縮性側索硬化（ALS）治療格局最近面臨的外部挑戰。我們親眼目睹了對肌萎縮性側索硬化症治療的巨大需求，當我們中的一個人遇到挫折時，整個社區都會受到影響。
We want to reiterate that we remain focused on our mission to support the broader community through research, treatments, advocacy and patient resources.
我們想重申，我們將繼續專注於我們的使命，即通過研究、治療、宣傳和患者資源爲更廣泛的社區提供支持。
We are dedicated to advancing our understanding of ALS through ongoing research, including continuing to evaluate the full potential of FDA-approved RADICAVA ORS (edaravone) and intravenous (IV) RADICAVA (edaravone). The U.S. approval of RADICAVA IV was based on Study 19 (MCI186-19), a randomized placebo-controlled Phase 3 study which was conducted prospectively in 137 people who met criteria identified from an exploratory analysis of the Phase 3 MCI186-16 study. In Study 19, on average, patients on RADICAVA lost 2.49 fewer points on the ALSFRS-R vs those in the placebo arm (p=0.0013).1
我們致力於通過持續的研究增進我們對肌萎縮性側索硬化症的理解，包括繼續評估經美國食品藥品管理局批准的RADICAVA ORS的全部潛力 （依達拉酮）和靜脈注射（IV）RADICAVA （依達拉豐）。美國對RADICAVA IV的批准基於第19號研究（MCI186-19），這是一項隨機安慰劑對照的3期研究，前瞻性地對137名符合3期MCI186-16 研究探索性分析中確定的標準的人群進行了前瞻性研究。在第19項研究中，平均而言，服用RADICAVA的患者 與安慰劑組相比，ALSFRS-R的損失分數減少了2.49分（p=0.0013）。1
RADICAVA ORS offers the same drug as RADICAVA IV in a different formulation.1,2 RADICAVA IV and RADICAVA ORS help slow the loss of physical function in patients with ALS by 33 percent vs. placebo, measured over 24-weeks by the ALS Functional Rating Scale-Revised (ALSFRS-R).1,2 The safety profile of RADICAVA IV was demonstrated in pooled placebo-controlled trials in which 184 patients with ALS were administered RADICAVA IV (60 mg) in 24-week treatment cycles.1 The safety profile of RADICAVA ORS was demonstrated in a 6-month, Phase 3, open-label clinical trial in 185 patients.1 In addition to contusion, gait disturbance, and headache reported with RADICAVA, fatigue was observed in 7.6% (14/185) of patients receiving RADICAVA ORS.1 Please see Important Safety Information below and Full Prescribing Information here.
RADICAVA ORS 提供與 RADICAVA IV 相同的藥物 用不同的表述。1,2 根據肌萎縮性側索硬化症功能評級量表修訂版（ALSFRS-R）在24周內測量，與安慰劑相比，RADICAVA IV和RADICAVA ORS有助於將肌萎縮性側索硬化症患者的身體機能喪失減緩33％。1,2 RADICAVA IV的安全性在合併安慰劑對照試驗中得到了證實，在該試驗中，184名肌萎縮性側索硬化症患者在24周的治療週期內接受了RADICAVA IV靜脈注射（60 mg）。1 一項針對185名患者的爲期6個月的3期開放式臨床試驗證實了RADICAVA ORS的安全性。1 除了RADICAVA報告的挫傷、步態障礙和頭痛外，在接受RADICAVA ORS治療的患者中，有7.6％（14/185）的患者出現疲勞。1 請參閱下面的 “重要安全信息” 和此處的 “完整處方信息”。
Over the past years, we have conducted real-world evidence (RWE) studies* to evaluate RADICAVA IV-treated ALS patients with non-RADICAVA patients.1 We are also gathering data on related factors, including healthcare resource utilization and patient outcomes. We believe the data gathered from RWE underscores our commitment to transparency and evidence-based practices.
在過去的幾年中，我們進行了真實世界證據（RWE）研究*，以評估接受RADICAVA靜脈注射治療的肌萎縮性側索硬化症患者和非拉迪卡瓦患者。1 我們還在收集有關相關因素的數據，包括醫療保健資源利用率和患者預後。我們認爲，從萊茵集團收集的數據凸顯了我們對透明度和循證實踐的承諾。
To date, in the U.S., RADICAVA IV 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 more than 2,300 HCPs.4-6 RADICAVA ORS and RADICAVA IV have been supported by a robust set of data from multiple MTPA-sponsored clinical trials, post-hoc analysis and RWE studies evaluating the efficacy and safety. These results have been published in over 40 peer-reviewed articles.
迄今爲止，在美國，RADICAVA IV和RADICAVA ORS已被用於治療超過14,600名肌萎縮性側索硬化症患者，治療天數超過180萬天，超過2300名HCP已開處方。4-6 RADICAVA ORS和RADICAVA IV得到了來自MTPA贊助的多項臨床試驗、事後分析以及評估療效和安全性的萊茵集團研究的一組可靠數據的支持。這些結果已發表在40多篇同行評審文章中。
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. In the U.S., RADICAVA and RADICAVA ORS are available via MTPA's network of specialty pharmacies and specialty distributors.
2015 年，依達拉豐被批准爲 RADICUT 用於在日本和韓國治療肌萎縮性側索硬化症。隨後，加拿大（2018年10月）、瑞士（2019年1月）、印度尼西亞（2020年7月）、泰國（2021年4月）、馬來西亞（2021年12月）和巴西（2024年2月）獲得了上市許可。RADICAVA 的上市許可 加拿大（2022年11月）和瑞士（2023年5月）和RADICUT批准了口服停藥 2022年12月，2.1％的口服混懸液在日本獲得監管部門的批准。在美國，RADICAVA和RADICAVA ORS可通過MTPA的專業藥房和專業分銷商網絡購買。
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.
超敏反應
RADICAVA（依達拉酮）和 RADICAVA ORS（依達拉酮）對依達拉奉或本品任何非活性成分有過敏史的患者禁用。RADICAVA 出現過敏反應（發紅、丘疹和多形紅斑）和過敏反應（蕁麻疹、血壓下降和呼吸困難）。
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.
應仔細監測患者是否有超敏反應。如果出現超敏反應，請停用 RADICAVA 或 RADICAVA ORS，按照標準護理進行治療，並進行監測直至病情緩解。
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.
亞硫酸鹽過敏反應
RADICAVA 和 RADICAVA ORS 含有亞硫酸氫鈉，這種亞硫酸鹽可能會引起過敏型反應，包括過敏症狀和易感人群危及生命或不太嚴重的哮喘發作。普通人群中亞硫酸鹽敏感性的總體患病率尚不清楚，但在哮喘患者中發生的頻率更高。
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.
不良反應
在接受Radicava治療的患者中報告的最常見的不良反應（≥ 10%）是挫傷（15%）、步態障礙（13%）和頭痛（10%）。在一項開放標籤研究中，在接受RADICAVA ORS治療的患者中，有7.6％也觀察到疲勞。
Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
懷孕
根據動物數據，RADICAVA和RADICAVA ORS可能會對胎兒造成傷害。
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 .
要報告疑似不良反應或產品投訴，請致電1-888-292-0058與三菱田邊製藥美國公司聯繫。您也可以通過 1-800-FDA-1088 或... 向 FDA 報告疑似不良反應。
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
指示
RADICAVA 和 RADICAVA ORS 適用於治療肌萎縮性側索硬化症 (ALS)。
For more information, including full Prescribing Information, please visit .
欲了解更多信息，包括完整的處方信息，請訪問。
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.
關於三菱田邊製藥美國有限公司
三菱田邊製藥美國公司（MTPA）總部位於新澤西州澤西城，是三菱田邊製藥公司（MTPC）的全資子公司。它由MTPC建立，旨在開發和推進我們的產品線，並在北美實現經批准的藥品的商業化。欲了解更多信息，請在 X（前身爲推特）、臉書和領英上訪問或關注我們。
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
關於三菱田邊製藥株式會社
三菱化學集團（MCG）的製藥部門三菱田邊製藥公司（MTPC）是世界上最古老的製藥公司之一，成立於1678年。MTPC總部位於日本製藥業的發源地大阪道修町。MCG在其管理政策 “創造未來” 中將醫療保健定位爲其戰略重點。MTPC的使命是 “爲所有面臨疾病的人創造希望”。爲此，MTPC正在研究中樞神經系統、免疫炎症、糖尿病和腎臟以及癌症等疾病領域。MTPC專注於 “精準醫學”，以提供治療滿意度高的藥物，此外還致力於開發 “藥丸周圍的解決方案”，以解決基於治療醫學的特定患者問題，包括疾病預防、症狀前疾病護理、預防惡化和預後。欲了解更多信息，請訪問
Media inquiries:
[email protected]
媒體查詢：
[電子郵件保護]
* These studies are limited only to patients with ALS who have commercial health coverage. Real-world data analyses have inherent limitations and are not intended to replace prospective clinical trials.
* 這些研究僅限於擁有商業健康保險的肌萎縮性側索硬化症患者。現實世界的數據分析有固有的侷限性，並不打算取代前瞻性的臨床試驗。
1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
2 Shimizu H, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197.
3 Brooks, B, et al. Intravenous edaravone treatment in ALS and survival: An exploratory, retrospective, administrative claims analysis. eClinicalMedicine. 2022; 52: 101590.
4 Data on file, MTPA.
5 Data on file, MTPA.
6 Data on file, MTPA.
1 RADICAVA 和 RADICAVA ORS 處方信息。新澤西州澤西城：三菱田邊製藥美國有限公司；2022年。
2 清水 H 等健康成人受試者口服懸浮液和靜脈注射依達拉酮製劑的生物等效性研究。 Clin Pharmacol 藥物開發 2021; 10 (10): 1188-1197。
3 布魯克斯，B，等。靜脈注射依達拉封治療肌萎縮性側索硬化症和存活率：探索性、回顧性、行政索賠分析。電子臨床醫學。2022年；52：101590。
4 存檔數據，MTPA。
5 存檔數據，MTPA。
6 存檔數據，MTPA。
SOURCE Mitsubishi Tanabe Pharma America
來源：美國田邊三菱製藥公司
譯文內容由第三人軟體翻譯。