JERSEY CITY, N.J., March 12, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of eleven abstracts covering research in amyotrophic lateral sclerosis (ALS) at the 2025 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference being held in Dallas, Texas, March 16-19.
“We are looking forward to presenting our latest ALS research, including an innovative study exploring how clinical algorithms may aid in the diagnosis of ALS,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. “We remain dedicated to advancing ALS research and fostering scientific dialogue at medical meetings and congresses on our mission to provide meaningful treatment options and help improve the lives of those affected by this disease.”
RADICAVA ORS® (edaravone) Studies:
Final efficacy and safety results from two multi-center, Phase 3b, double-blind, parallel group studies will be presented, including a comparison of daily dosing of RADICAVA ORS® (edaravone) with the FDA-approved on/off regimen, assessed at 48 weeks (MT-1186-A02) and its extension study (MT-1186-A04). Safety data from a Phase 3 open-label safety extension study for up to 96 weeks (MT-1196-A03) will also be shared. An additional presentation will examine the long-term function and survival of patients treated with RADICAVA ORS using data from propensity score-matched patients in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.
- 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 ALS
(Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03)
(Stephen Apple, M.D.; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Phase 3b Study MT-1186-A04 Extension Study to Evaluate the Continued Efficacy and Safety of Radicava ORS® (Oral Edaravone) for up to an Additional 48-Weeks in Patients With Amyotrophic Lateral Sclerosis
(Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Analysis of Long-term Function and Survival of Radicava ORS® (Oral Edaravone)-Treated Patients With Amyotrophic Lateral Sclerosis vs Propensity Score–Matched PRO-ACT Historical Controls
(Stephen Apple, M.D.; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025
Real World Data:
Presentations will highlight a clinical algorithm designed to analyze electronic medical record (EMR) data of neurologists, which aims to reduce delays in ALS diagnosis and treatment. Findings from the ALS/Motor Neuron Disease National History Consortium database will provide insights into the survival, treatment patterns and clinical outcomes of patients treated for ALS. In addition, studies examining referral patterns for ALS diagnosis, as well as demographics and healthcare resource utilization (HCRU) trends across specialty and non-specialty treatment centers, will be shared. Further, two studies will explore point-of-care quality classifications and at-home telespirometry assessments, evaluating forced vital capacity as well as erect and supine slow vital capacity in individuals with ALS.- Smartphone Application-Mediated Supervised At-Home Telespirometry Erect and Supine Slow Vital Capacity (eSVC/sSVC) Measurements in Subjects With Amyotrophic Lateral Sclerosis Identify Statistically Significant Differences in eSVC/sSVC Decline as Function of Non-Invasive Ventilation Treatment Status [NCT05106569]
(Stephen Apple, M.D.; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Smartphone Application–Mediated, Supervised, At-Home Telespirometry Vital Capacity Measurements in Amyotrophic Lateral Sclerosis: Comparison of American Thoracic Society/European Respiratory Society Point-of-Care Quality Assessment Algorithms Implemented for Slow Vital Capacity and Forced Vital Capacity [NCT05106569]
(Stephen Apple, M.D.; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Referral Patterns for Patients With Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database
(Malgorzata Ciepielewska, M.S.; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Investigating Application of a Clinical Algorithm on Real-World Electronic Medical Record Data for Earlier Detection of Amyotrophic Lateral Sclerosis
(Dung Pham, Ph.D.; MTP-CA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Treatment of Amyotrophic Lateral Sclerosis in General and Specialist US Healthcare Settings: Results From a Real-World Survey
(Malgorzata Ciepielewska, M.S.; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 - Survival Benefits and Treatment Patterns of Edaravone–Treated People With Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium
(Malgorzata Ciepielewska, M.S.; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025
Preclinical Data:
Data from a preclinical study examining the effects of edaravone on spinal motor neurons derived from an ALS patient carrying the A382T mutation in TDP-43, as analyzed through a comprehensive transcriptomic approach, will be presented.Transcriptomic Signature Induced by Edaravone in Motor Neurons From an ALS Patient With a TDP-43 Mutation (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025
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
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
IMPORTANT SAFETY INFORMATION
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.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.
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.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.Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.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.
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).For more information, including full Prescribing Information, please visit 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. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and 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, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. 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 by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is 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 https://www.mt-pharma.co.jp/e/Media inquiries:
Media_MTPA@mt-pharma-us.com1 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-to-showcase-new-research-findings-in-als-at-2025-mda-clinical-and-scientific-conference-302399001.html
SOURCE Mitsubishi Tanabe Pharma America
