Mitsubishi Tanabe Pharma America to Present Eight ALS Research Posters at 2025 NEALS Annual Meeting

Research to feature RADICAVA ORS^® (edaravone), biomarker findings, real-world safety data and digital health innovation

JERSEY CITY, N.J., Oct. 2, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that eight poster presentations highlighting new research in amyotrophic lateral sclerosis (ALS) will be shared at the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) 2025 Annual Meeting, taking place Oct. 7-10 in Clearwater, Florida and online.

"We look forward to presenting a wide range of new ALS research at this year's NEALS meeting, from real-world data on RADICAVA ORS to advances in digital health and insights into the diagnostic journey," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "These studies reflect our commitment to addressing unmet needs in ALS care and to developing innovative solutions aimed at improving outcomes for people living with ALS."

RADICAVA ORS Data:
New data will be presented on the safety and a potential biomarker for RADICAVA ORS, as well as long-term outcomes from real-world registry studies. A three-year pharmacovigilance analysis of more than 12,000 U.S. patients with ALS reported no new safety concerns. In addition, an exploratory post hoc analysis of neutrophil-to-lymphocyte ratio (NLR) examined treatment response by baseline NLR, with findings suggesting potential utility of NLR as a prognostic biomarker. An encore analysis from the SUNRISE Japan study compared with the Japanese Consortium for ALS Research (JaCALS) registry will provide additional insights into the long-term outcomes in real-world ALS patients treated with edaravone.

• Neutrophil-to-Lymphocyte Ratio as a Novel Biomarker for Edaravone Oral Suspension–Treated Patients With Amyotrophic Lateral Sclerosis vs Propensity Score–Matched PRO-ACT Historical Placebo Controls (Manabu Hirai, M.S.; MTPC)
  Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8
• Safety Data Summarizing 3 Years of Radicava ORS^® (Edaravone) Using Postmarketing Pharmacovigilance From United States–based Patients With Amyotrophic Lateral Sclerosis (Stephen Apple, M.D.; MTPA)
  Poster Session 2: 4:20 p.m. – 6:20 p.m. EDT, October 9
• Evaluation of Long-Term Prognosis of Edaravone in ALS Patients: A Real-World Comparative Study Using SUNRISE Japan and JaCALS Registry Data (Manabu Hirai, M.S.; MTPC)
  Poster Session 2: 4:20 p.m. – 6:20 p.m. EDT, October 9

Digital Health Insights:
Three posters will highlight the potential role of smartphone-based, at-home telespirometry in ALS management. A prospective six-month study evaluated edaravone-treated patients and reported differences in ALS Functional Rating Scale-Revised (ALSFRS-R) decline based on non-invasive ventilation (NIV) status. Further analyses emphasized the importance of accounting for NIV use in clinical studies. A separate outcomes study also assessed the feasibility, ease of use and perceived benefits of at-home telespirometry, with participants reporting increased involvement in care and greater awareness of symptoms.

• At-Home Telespirometry Identifies Significantly Slower Decline of ALS Functional Rating Scale-Revised Total Score but not Erect/Supine Slow Vital Capacity in Edaravone-Treated ALS Subjects Not Requiring Non-Invasive Ventilation [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University)
  Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8
• Smartphone Application–Mediated, Supervised, At-Home Telespirometry Identifies Statistically Significant Differences in Erect and Supine Slow Vital Capacity and ALSFRS-R Decline as a Function of Non-invasive Ventilation Treatment Status in Multicenter, Prospective, Longitudinal, Observational Clinical Study [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University)
  Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8
• Smartphone Application–Mediated, Respiratory Therapist–Supervised, At-Home Telespirometry Erect/Supine Slow Vital Capacity Measurements in Subjects With ALS: Patient-Reported 5-Item Likert Scale Feasibility and Participation End-of-Study Outcomes Questionnaire Confirms Ease of Implementation and Identifies Per-Subject Benefits (Eufrosina I. Young, M.D.; SUNY Upstate Medical University)
  Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8

Diagnostic Journey and Disease Burden:
Posters will share real-world data from the Adelphi ALS Disease Specific Programme highlighting some of the challenges faced by patients and caregivers: median time for first consultation to ALS diagnosis was approximately five months, and one in four patients was initially misdiagnosed, contributing to delays in care. Additional findings showed a substantial financial burden and that more than 90% of patients relied on caregiver support, most often from partners or spouses.

• Characteristics and Disease Burden of People With Amyotrophic Lateral Sclerosis in a United States-Based Population: Analysis of Real-World Data (Malgorzata Ciepielewska, M.S.; MTPA)
  Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8
• Diagnostic Journey in a United States-Based Population of People With Amyotrophic Lateral Sclerosis: Analysis of Real-World Data (Malgorzata Ciepielewska, M.S.; MTPA)
  Poster Session 2: 4:20 p.m. – 6:20 p.m. EDT, October 9

About RADICAVA ORS^® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS^® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. 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. Each 105 mg (5mL) dose of 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), Australia (February 2023) 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 ORS, along with the previously available IV RADICAVA^® (edaravone), have been used to treat over 19,000 people with ALS, with over 2.5-million days of therapy, and have been prescribed by over 2,600 HCPs.^2-4

INDICATION
RADICAVA ORS^® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions
RADICAVA ORS^® (edaravone) is 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.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions
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^® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy
Based on animal data, 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.

Please see the full Prescribing Information, also available at www.RADICAVAORS.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) 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. 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 https://www.mt-pharma.co.jp/e/.

Media inquiries:
Media_MTPA@mt-pharma-us.com 

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.

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SOURCE Mitsubishi Tanabe Pharma America