Mitsubishi Tanabe Pharma America Showcases Breadth of ALS Data at 21st Annual NEALS Meeting

Presentations Consist of New Clinical and Real-World Data Evaluating Treatment with RADICAVA® (edaravone) and RADICAVA ORS® (edaravone)

JERSEY CITY, N.J., Nov. 1, 2022 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that six presentations on amyotrophic lateral sclerosis (ALS) will be shared at the 21st Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting, being held in Clearwater, Fla., from November 1-3.

"We are eager to unveil a broad range of ALS research at the NEALS meeting – from real-world analyses of treatment and patient-reported outcomes to interim results from the ongoing REFINE-ALS biomarker study, and new data from a subgroup analysis of the global Phase 3 safety trial of RADICAVA ORS® (edaravone)," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These results highlight our tireless efforts to deepen our knowledge of this disease and further understand the effects of edaravone as a treatment option."

MTPA's posters will be viewable throughout the conference. Presentations include:

REFINE-ALS Biomarker Study
Results from an interim analysis of the prospective, observational, longitudinal, multi-center REFINE-ALS Phase 4 study will be presented. The ongoing study is designed to identify specific biomarkers to measure the effect of edaravone in ALS, as well as evaluate clinical outcomes for edaravone in real-world settings. REFINE-ALS is a NEALS-affiliated clinical trial sponsored by MTPA and conducted in collaboration with the Massachusetts General Hospital Neurological Clinical Research Institute.

• Interim Analysis of the Radicava/Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (James D. Berry, M.D., MPH; Massachusetts General Hospital)

Additional Real-World Data
Presentations include findings from a real-world analysis of time to progression milestones in patients with ALS treated with intravenous (IV) RADICAVA® (edaravone) utilizing de-identified data from Optum's Clinformatics® Data Mart (CDM) database, as well as an analysis of patient-reported outcomes using de-identified data from the Adelphi ALS Disease Specific Programme™ to measure quality of life (QoL) in ALS patients in the U.S. receiving treatment with RADICAVA vs. those who did not receive the treatment.

• Longer Milestone-free Time in Patients With Amyotrophic Lateral Sclerosis Treated With IV Edaravone vs IV Edaravone-naïve: Results From an Administrative Claims Analysis (James D. Berry, M.D., MPH; Massachusetts General Hospital)
• Treatment and Patient-Reported Outcomes Among People With ALS in the US: Results From a Real-World Study (Malgorzata Ciepielewska, M.S.; MTPA)

RADICAVA ORS Presentations
48-week safety results from the global Phase 3 multi-center, open-label clinical trial ( MT-1186-A01 ) evaluating RADICAVA ORS in patients with ALS will be presented, as well as a new subgroup analysis of the study assessing safety results in study participants who had prior exposure to the IV formulation vs. those who did not, helping to determine whether former RADICAVA-treated patients can be safely transitioned to the oral formulation. Additionally, study design details from the ongoing, Phase 3b multi-center, double-blind, parallel-group study ( MT-1186-A02 ) comparing two dosing regimens for RADICAVA ORS to evaluate its long-term efficacy and safety over 48 weeks will be shared. Both the completed A01 and ongoing A02 studies are sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA).

• Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (MT-1186-A01): 48-Week Results (Angela Genge, M.D., FRCP; Montreal Neurological Institute and Hospital)
• Subgroup Analysis of a Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone in Patients with Amyotrophic Lateral Sclerosis (MT-1186-A01): Intravenous Edaravone-Naïve Versus Intravenous Edaravone-Experienced Patients (Angela Genge, M.D., FRCP; Montreal Neurological Institute and Hospital)
• Phase 3b, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate Efficacy and Safety of Investigational Oral Edaravone Administered Over 48 Weeks in Patients with Amyotrophic Lateral Sclerosis (MT-1186-A02) (Jeffrey Rothstein, M.D., Ph.D.; Department of Neurology, School of Medicine, Johns Hopkins University)

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 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 Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), 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, RADICAVA was approved for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), China (July 2019), Indonesia (July 2020), Thailand (April 2021) and Malaysia (December 2021). To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 8,000 patients, with over 1.1-million days of therapy, and have been prescribed by nearly 2,000 HCPs.2,3

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's (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Development America, Inc.

The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation's 100 percent-owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. For more information, please visit https://mt-pharma-development-america.com/.

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of the Mitsubishi Chemical Group, 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. The Mitsubishi Chemical Group 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 prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. 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.com

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1RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
2Data on file. Mitsubishi Tanabe Pharma America, Inc.
3Data on file. Mitsubishi Tanabe Pharma America, Inc.

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SOURCE Mitsubishi Tanabe Pharma America, Inc.