Mitsubishi Tanabe Pharma America to Showcase New RADICAVA ORS (Edaravone) Real-World Data at 2024 Academy of Managed Care Pharmacy Nexus Meeting
Mitsubishi Tanabe Pharma America to Showcase New RADICAVA ORS (Edaravone) Real-World Data at 2024 Academy of Managed Care Pharmacy Nexus Meeting
JERSEY CITY, N.J., Oct. 10, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of real-world data from a retrospective analysis of healthcare resource utilization (HCRU) among people with amyotrophic lateral sclerosis (ALS) treated with RADICAVA ORS (edaravone). The data, drawn from a U.S.-based administrative claims database, will be shared as part of the Academy of Managed Care Pharmacy (AMCP) 2024 Annual Meeting, being held in Las Vegas, Nev., October 14-17.
美國新澤西澤西市，2024年10月10日 / PRNewswire / - 今天，Mitsubishi Tanabe Pharma America, Inc. (MTPA)宣佈了關於使用RADICAVA ORS（依達腺苷）治療肌萎縮側索硬化症（ALS）患者的衛生資源利用（HCRU）的實際數據的回顧性分析報告。這些數據來自美國的行政索賠數據庫，並將作爲2024年學會管理藥學學會（AMCP）年會的一部分在內華達州拉斯維加斯舉行，時間爲10月14日至17日。
"We are excited to present our latest real-world data on the healthcare resource utilization of ALS patients treated with RADICAVA ORS at this year's ACMP Nexus conference," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "By understanding how this treatment is utilized across different patient demographics and insurance types, we aim to support more informed healthcare strategies."
「我們很高興能在今年的ACMP Nexus會議上展示有關接受RADICAVA ORS治療的ALS患者衛生資源利用的最新實際數據，」MTPA醫學事務副總裁Gustavo A. Suarez Zambrano 說道。 「通過了解這種治療在不同患者人口統計學和保險類型中的使用情況，我們旨在支持更明智的衛生保健策略。」
Presentation Details:
The presentation will share updated results from a real-world observational analysis describing the demographics, clinical characteristics and HCRU of ALS patients treated with RADICAVA ORS. The data, drawn from Optum's de-identified Clinformatics Data Mart (CDM), includes insights into the treatment patterns of two groups: those who initially received intravenous edaravone and switched to oral edaravone, and those who were edaravone-naïve prior to starting oral treatment.
演示說明：
演示將分享最新的實際觀察分析結果，描述接受RADICAVA ORS治療的ALS患者的人口統計學、臨床特徵和衛生資源利用情況。這些數據來自Optum的去身份化Clinformatics Data Mart（CDM），包括兩組治療方案的見解：那些最初接受靜脈依達腺苷並轉爲口服依達腺苷的患者；以及那些在開始口服治療之前不曾接受依達腺苷治療的患者。
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Healthcare Resource Utilization of Oral Edaravone-Treated Patients with Amyotrophic Lateral Sclerosis Enrolled in an US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA)
Poster Session: 5 p.m. – 7:00 p.m. PDT, October 15; 1:00 p.m. – 2:30 p.m. PDT, October 16
- 在美國行政索賠數據庫登記的接受口服依達腺苷治療的肌萎縮側索硬化症患者的衛生資源利用（Malgorzata Ciepielewska 等；MTPA）
海報展示時間：晚上5點至晚上7點，PDT，10月15日；下午1點至下午2點30分，PDT，10月16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
有關RADICAVA（艾達那肽）和RADICAVA ORS（艾達那肽口服液）
美國食品和藥物管理局（FDA）於2017年5月5日批准了RADICAVA（艾達那肽），並於2022年5月12日批准了口服制劑RADICAVA ORS（艾達那肽）用於治療肌萎縮側索硬化症（ALS）。2024年，FDA基於該創新口服制劑對患者護理的主要貢獻，認可了RADICAVA ORS的孤兒藥物獨家性。RADICAVA通過靜脈輸注進行爲期28天的循環。每次注射60毫克藥物需要60分鐘。在初始循環中，治療每日靜脈注射14天，然後進行爲期兩週的停藥期。隨後的每個循環在14天的期限內每日靜脈注射10天，然後進行爲期兩週的停藥期。RADICAVA ORS在初始治療週期中每日連續服用14天，然後進行爲期14天的停藥期。對於後續的治療週期，RADICAVA ORS在14天的期限內每日服用10天，然後進行爲期14天的停藥期。RADICAVA ORS應在隔夜禁食後的早晨服用。患者在服用RADICAVA ORS後的1小時內不得進食或飲用（除水外）。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 16,000 people with ALS, with over 2.0-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4
伊達拉韋首次由三菱坦貝製藥（MTPC）爲治療ALS而進行發現和研發，由三菱坦貝製藥美國公司（MTPA）在美國推廣。 MTPC集團自2001年開始通過一個爲期13年的迭代臨床平台進行ALS研究。 2015年，伊達拉韋在日本和韓國獲得了治療ALS的批准。 隨後，在加拿大（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）獲得了上市授權。 RADICAVA口服懸液在加拿大（2022年11月）和瑞士（2023年5月）獲得了上市授權，而RADICUt口服懸液2.1%於2022年12月獲得了日本的監管批准。 截至目前，在美國，已有超過16,000人使用RADICAVA和RADICAVA ORS治療ALS，治療超過2.0百萬天，被超過2,400位醫療保健專業人士處方。
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.
過敏反應
RADICAVA（依達拉奉）和RADICAVA ORS（依達拉奉）不能用於過敏史爲依達拉奉或本品任何非活性成分的患者。RADICAVA會引起過敏反應（紅斑，丘疹和多形性紅斑），並引起過敏性休克（蕁麻疹、血壓下降和呼吸困難）的病例。
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.
患者應仔細監測過敏反應。如果出現過敏反應，停用雷地卡瓦或雷地卡瓦ORS，根據標準護理進行治療，並監測直到病情緩解。
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.
過敏反應
RADICAVA和RADICAVA ORS含有亞硫酸氫鈉，這是一種會導致過敏類反應的亞硫酸鹽，包括易感人群中的過敏症狀和威脅生命的或不那麼嚴重的哮喘發作。一般人群中亞硫酸鹽過敏的患病率前景不明，但哮喘患者中發生的可能性更大。
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.
副作用
RADICAVA治療的患者中最常見的不良反應（≥10％）是淤傷（15％），步態障礙（13％）和頭痛（10％）。在一項開放性研究中，RADICAVA ORS治療的患者中還觀察到了疲勞症狀，出現率爲7.6％。
Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
懷孕和哺乳期
基於動物數據，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，請聯繫三菱田貝製藥美國公司，電話爲1-888-292-0058。您還可以向FDA報告疑似不良反應，電話爲1-800-FDA-1088或網址http://www.fda.gov/medwatch。
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
適應症
RADICAVA和RADICAVA ORS用於治療肌萎縮性側索硬化（ALS）的症狀。
For more information, including full Prescribing Information, please visit .
有關更多信息，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.
關於日本北辰藥品美國公司。
總部位於新澤西州澤西市的Mitsubishi Tanabe Pharma America, Inc.（MTPA）是三菱田邊製藥株式會社（MTPC）的全資子公司。它是由MTPC設立的，旨在開發和推進我們的產品管線，以及在北美推廣已批准的藥品。更多信息，請訪問網站或關注我們在X（前稱Twitter）、Facebook和LinkedIn上的主頁。
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
三菱丹波製藥株式會社（MTPC）是三菱化學集團（MCG）的製藥部門，是世界上最古老的藥品公司之一，成立於1678年。MTPC總部位於日本製藥業的發源地大正町，大阪。MCG將醫療保健作爲其管理政策中的戰略重點，「開創未來」。MTPC制定了「爲所有面臨疾病的人創造希望」的使命。爲此，MTPC致力於中樞神經系統，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」，提供高滿意度治療的藥物，並致力於開發「圍繞藥物」的解決方案，以根據治療藥物解決特定患者關注的問題，包括疾病預防，症前病護理，疾病惡化預防和預後。欲了解更多信息，請訪問 。
Media inquiries:
[email protected]
媒體查詢：
[email protected]
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處方信息。新澤西市，NJ：三菱塔拿別製藥美國公司；2022。
2公司資料。三菱塔拿別製藥美國公司。
3公司資料。三菱塔拿別製藥美國公司。
4公司資料。三菱塔拿別製藥美國公司。
SOURCE Mitsubishi Tanabe Pharma America
見Mitsubishi Tanabe Pharma America。
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