Mitsubishi Tanabe Pharma America Announces Presentations in ALS at 2023 MDA Clinical & Scientific Conference

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Mitsubishi Tanabe Pharma America, Inc.

Mar 17, 2023, 09:00 ET

Presentations Spotlight Real-World and Clinical Studies of RADICAVA^® (edaravone) and RADICAVA ORS^® (edaravone) in ALS

JERSEY CITY, N.J., March 17, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced three presentations on amyotrophic lateral sclerosis (ALS) as part of the 2023 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, being held virtually and in Dallas, Tex., March 19-22.

"We look forward to sharing our ALS research findings from the real-world analyses of treatment outcomes with RADICAVA^® (edaravone), and details from our Phase 3b trial evaluating the long-term use of RADICAVA ORS^® (edaravone)," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These presentations reflect our determination to not only broaden our expertise in ALS, but to continue sharing key insights that have a meaningful impact on the patient and medical communities."

MTPA's posters will be viewable in-person and virtually during the conference, as well as showcased in the Exhibit Halls from 6:00-8:00 p.m. CT. Presentations include:

Real-World Data
Findings from a real-world analysis of time to progression milestones in people with ALS treated with RADICAVA utilizing de-identified data from Optum's Clinformatics^® Data Mart (CDM) database will be shared, as well as an analysis of baseline demographic and clinical characteristics in people treated with and without RADICAVA in a real-world setting, based on a database of administrative health claims across the U.S.

Longer Milestone-free Time in IV Edaravone-treated vs IV Edaravone-naïve Amyotrophic Lateral Sclerosis Patients: An Administrative Claims Analysis (James D. Berry, M.D., MPH; Massachusetts General Hospital)
Understanding Characteristics of Patients with ALS with and without Intravenous Edaravone Treatment: A Retrospective Administrative Claims Analysis (Malgorzata Ciepielewska, MS; MTPA)

RADICAVA ORS
Study design details from the global, multi-center, double-blind, Phase 3b study (MT-1186-A02) comparing two dosing regimens for RADICAVA ORS to evaluate its long-term efficacy and safety over 48 weeks will be presented. The ongoing study is sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA).

Phase 3b, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate Efficacy and Safety of Oral Edaravone Administered Over 48 Weeks in Patients with Amyotrophic Lateral Sclerosis (MT-1186-A02) (Alejandro Salah, M.D., Ph.D.; MTPA)

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, 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 in November 2022, 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 10,000 people with ALS, with over 1.2 million days of therapy, and have been prescribed by nearly 2,000 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'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/.

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¹ RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.

²Data 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.