Mitsubishi Tanabe Pharma America to Present Latest Neurodegenerative Research at the 2024 American Neurological Association 149th Annual Meeting
Mitsubishi Tanabe Pharma America to Present Latest Neurodegenerative Research at the 2024 American Neurological Association 149th Annual Meeting
Posters will highlight findings from studies evaluating investigational ND0612 in Parkinson's disease and RADICAVA ORS (edaravone) in ALS
將重點介紹對研究中的ND0612在帕金森病和羅地卡梵（edaravone）在ALS中的評估結果
JERSEY CITY, N.J., Sept. 12, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced four presentations will be shared at the American Neurological Association (ANA) 2024 Annual Meeting being held September 14-17 in Orlando, Fla. The presentations will discuss two abstracts in Parkinson's disease (PD) and two in amyotrophic lateral sclerosis (ALS).
2024年9月12日，美國東部時間，新澤西州澤西城/PRNewswire/ - 三菱丹貝製藥美國公司（MTPA）今天宣佈將在2024年美國神經學協會（ANA）年會上分享四個報告。該年會將於9月14日至17日在佛羅里達州奧蘭多舉行。這些報告將討論兩個帕金森病（PD）的摘要和兩個肌萎縮性側索硬化症（ALS）的摘要。
"We look forward to sharing the latest findings from our studies in Parkinson's disease and ALS at this year's ANA meeting," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "Our presentations underscore our unwavering commitment to understanding the high unmet needs within these patient communities through continuous research and innovation."
「我們期待在今年的ANA會議上分享我們在帕金森病和ALS中的最新研究成果，」三菱丹貝製藥美國公司（MTPA）醫學事務副總裁Gustavo A. Suarez Zambrano萬.D.表示。「我們的報告凸顯了我們對於通過持續的研究和創新來了解這些患者群體的高度未滿足需求的承諾。」
PD data to be presented at the meeting include:
將在會議上介紹的帕金森病數據包括：
Investigational ND0612
Presentations include findings from subgroup analyses from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy and safety of investigational ND0612 across a range of sociodemographic groups of people with PD experiencing motor fluctuations, as well as findings from an integrated analysis characterizing infusion site reactions reported in patients treated with ND0612.
研究中的ND0612
報告將包括來自關鍵性3期BouNDless試驗（NCT04006210）的次組分析的結果，該試驗評估了研究中的ND0612在不同人群中帕金森病患者經歷運動波動時的療效和安全性，以及對接受ND0612治療的患者報告的輸液部位反應的綜合分析結果。
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Efficacy of ND0612 a 24-hour Subcutaneous Levodopa/Carbidopa Infusion for People with Parkinson's Disease Experiencing Motor Fluctuations: Subgroup-Analyses from a Randomized, Controlled Phase 3 Study (Antoinette Harrison, PharmD, BCGP, PCPP, FASCP; MTPA)
Poster #M2.123: 6:00 p.m. – 7:30 p.m. EST, September 16 -
Characterization of Infusion Site Reactions With 24-hour Subcutaneous Infusion of ND0612 (Antoinette Harrison, PharmD, BCGP, PCPP, FASCP; MTPA)
Poster #M2.124: 6:00 p.m. – 7:30 p.m. EST, September 16
- ND0612作爲一種24小時皮下左多巴/卡比多巴（Levodopa/Carbidopa）輸注療法，用於帕金森病患者經歷運動波動：基於隨機對照的3期研究的次組分析結果（Antoinette Harrison，PharmD，BCGP，PCPP，FASCP；MTPA）
海報編號#M2.123：美國東部時間下午6:00 - 7:30，9月16日 - ND0612（Antoinette Harrison，PharmD，BCGP，PCPP，FASCP；MTPA）的24小時皮下輸液的輸液部位反應表徵
海報#M2.124：下午6:00 - 7:30（EST），9月16日
ALS data to be presented at the meeting include:
會議上將提供的ALS數據包括：
RADICAVA ORS
Final data from the global, double-blind Phase 3b study MT-1186-A02 will be showcased, including the post-marketing study of an investigational once-daily dosing regimen of RADICAVA ORS (edaravone) to evaluate whether investigational daily dosing displayed superior efficacy vs. the approved on/off dosing regimen of oral edaravone in patients with ALS over 48 weeks. In addition, full results from the RADICAVA ORS Phase 3 open-label safety extension study (MT-1186-A03), which spans 96 weeks, will be presented.
RADICAVA 口服液
全球範圍內，雙盲的30億期的Mt-1186-A02的最終數據將會展示，包括一項RADICAVA 口服液（edaravone）一日一次的調查性用藥方案的後期市場研究，以評估一日一次的調查性用藥方案是否在48周內顯示出優越性療效，與ALS患者獲批的間斷用藥方案相比。此外，將會呈現RADICAVA 口服液30億期開放標籤的安全性擴展研究（Mt-1186-A03）的完整結果，該研究將持續96周。
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Phase 3b Study MT-1186-A02 to Investigate the Superiority of Daily Dosing vs the FDA-approved On/Off Regimen of Oral Edaravone in Patients with Amyotrophic Lateral Sclerosis (Alejandro Salah, M.D. Ph.D., MBA, MHA; MTPA)
Poster #M2.029: 6:00 p.m. – 7:30 p.m. EST, September 16 -
Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Alejandro Salah, M.D. Ph.D., MBA, MHA; MTPA)
Poster #M2.046: 6:00 p.m. – 7:30 p.m. EST, September 16
- 調查性使用每日用藥與FDA批准的口服edaravone間斷用藥的優越性研究，針對肌萎縮性側索硬化症患者（Alejandro Salah萬.D. Ph.D., MBA, MHA; MTPA）的第30億期Mt-1186-A02研究
海報#M2.029：下午6:00 - 7:30（EST），9月16日 - ALS患者口服edaravone96週期安全性開放標籤擴展研究（Mt-1186-A03）（Alejandro Salah萬.D. Ph.D., MBA, MHA; MTPA）
海報編號＃M2.046：美國東部時間晚上6:00至7:30，9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 1.9-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4
艾達那肽由三菱坦貝製藥株式會社（MTPC）爲肌萎縮側索硬化症（ALS）發現和開發，並由三菱坦貝製藥美國公司（MTPA）在美國商業化。MTPC集團公司從2001年開始進行ALS研究，經過13年的迭代臨床平台研究。2015年，艾達那肽作爲RADICUTC被批准用於日本和韓國的ALS治療。後來，RADICAVA獲得了加拿大（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）的市場授權。RADICAVA口服懸液在加拿大（2022年11月）和瑞士（2023年5月）獲得市場授權，RADICUTC口服懸液2.1％在2022年12月獲得日本的監管批准。到目前爲止，在美國，RADICAVA和RADICAVA ORS已被用於治療超過16,000名肌萎縮側索硬化症患者，累計治療時間超過1.9百萬天，並由超過2,400名醫療保健專業人員開處方。2-4
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 .
欲了解更多信息，包括完整處方信息，請訪問。
About ND0612
ND0612 is an investigational drug-device combination therapy – a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC).
關於ND0612
ND0612是一種正在研究的藥物-器械結合療法——一種24小時/天、持續皮下（SC）輸注液體左旋多巴/卡比多巴（LD/CD），用於治療帕金森病（PD）患者的運動波動。正在開發ND0612的研究工作由Mitsubishi Tanabe Pharma Corporation（MTPC）的全資子公司NeuroDerm Ltd.領導。
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公司。
位於新澤西州澤西城的Mitsubishi Tanabe Pharma America，Inc.（MTPA）是Mitsubishi Tanabe Pharma Corporation（MTPC）的全資子公司。它成立於MTPC，旨在開發和推進我們的研究管道，以及在北美銷售已批准的醫藥產品。欲了解更多信息，請訪問或關注我們的 X （曾用名Twitter）,, Facebook和頁面。LinkedIn.
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 .
關於三井製藥株式會社
三菱棕櫚醫療株式會社（簡稱MTPC），是三菱化學集團（MCG）的醫藥業務部門，成立於1678年，是世界上最古老的藥品公司之一。MTPC總部位於大阪渡船町，是日本製藥工業的發源地。在其管理方針「打造未來」中，MCG將醫療保健視爲戰略重點。MTPC的任務是「爲面臨疾病的全員創造希望」。爲此，MTPC致力於研究中樞神經系統、免疫炎症、糖尿病、腎臟和癌症等疾病領域。MTPC專注於「精準醫學」，提供治療效果滿意度高的藥品；此外，還致力於開發基於治療醫學的特色患者解決方案，包括疾病預防、前徵疾病護理、病情惡化預防和疾病預後。如需了解更多信息，請訪問RADICAVA和RADICAVA ORS的處方信息。新澤西州澤西城：三菱棕櫚醫療美國公司，2022。.
About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at or follow the Company on LinkedIn.
關於NeuroDerm有限公司
NeuroDerm Ltd. 是Mitsubishi Tanabe Pharma Corporation（MTPC）的全資子公司，總部位於以色列，旨在通過創新的藥物-器械組合療法和技術減輕疾病負擔，改善患者及其家人的生活質量。NeuroDerm是一家集成的製藥和醫療技術公司，正在開發中樞神經系統（CNS）產品候選。欲了解更多信息，請訪問NeuroDerm的網站或關注該公司LinkedIn.
Media inquiries:
[email protected]
媒體詢問:
[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。
