Mitsubishi Tanabe Pharma America Announces Presentations in ALS at 34th International Symposium on ALS/MND

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JERSEY CITY, N.J., Dec. 5, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that four abstracts in amyotrophic lateral sclerosis (ALS) will be presented at the Motor Neurone Disease Association (MNDA) 34^th International Symposium on ALS/MND, being held in Basel, Switzerland, from December 6-8.

"We're eager to participate in this year's symposium, where we will share recent insights from our real-world and clinical studies evaluating RADICAVA ORS^® (edaravone) and RADICAVA^® (edaravone) in ALS, as well as details from a prospective study utilizing home-based respiratory monitoring," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "Our hope is that these presentations complement the insights gathered during clinical trials and provide useful information to help educate practitioners about treatment options for ALS, and reinforce the importance of continued research of the disease."

MTPA's posters will be displayed during poster sessions held in the Event Halle on December 6 and 7. Presentations include:

RADICAVA ORS
A preliminary analysis of demographics and clinical characteristics in people with ALS treated with RADICAVA ORS, as part of an ongoing study utilizing U.S.-based administrative claims data from Optum's Clinformatics^® Data Mart (CDM), will be presented, in addition to study design details from the global, multi-center, double-blind, Phase 3b MT-1186-A04 study comparing two dosing regimens for RADICAVA ORS to evaluate its continued efficacy and safety in ALS.

• A Preliminary Analysis of Oral Edaravone-Treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA)
  Poster Session A (Part 2), 6:45 p.m. – 7:45 p.m. CET, Dec. 6
  
  
• Phase 3b Extension Study Evaluating Superiority of Daily vs Approved On/Off Oral Edaravone Dosing in Patients with Amyotrophic Lateral Sclerosis (Steve Apple, M.D.; MTPA)
  Poster Session A (Part 2), 6:45 p.m. – 7:45 p.m. CET, Dec. 6

REFINE-ALS Biomarker Study and Additional Real-World Data
Results from an interim analysis of the prospective, observational, longitudinal, multi-center Phase 4 REFINE-ALS study, designed to identify predictive and pharmacodynamic biomarkers to measure the effects of edaravone in ALS, as well as evaluate clinical outcomes in real-world settings, will be presented. The ongoing study is sponsored by MTPA and conducted in collaboration with the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (MGH). Additionally, updates from a prospective study to evaluate slow vital capacity (SVC) in erect-seated (eSVC) and supine (sSVC) positions using in-clinic and in-home, portable spirometry will be presented.

• Interim Analysis of the Radicava/Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (Steve Apple, M.D.; MTPA)
  Poster Session B (Part 1), 5:45 p.m. – 6:45 p.m. CET, Dec. 7
  
  
• Internet-Supervised Home-Based Slow Vital Capacity (SVC) Spirometry through Telemedicine in Amyotrophic Lateral Sclerosis – Prospective Multi-Center Observational Study (Eufrosina Young, M.D.; State University of New York Upstate Medical University)
  Poster Session B (Part 1), 5:45 p.m. – 6:45 p.m. CET, Dec. 7

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). 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) and Malaysia (December 2021). 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 12,000 people with ALS, with over 1.57-million days of therapy, and have been prescribed by over 2,200 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. 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 https://www.mt-pharma.co.jp/e/.

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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.

SOURCE Mitsubishi Tanabe Pharma America, Inc.