Data Include 48-Week Findings from Global Phase 3 Clinical Trial and New Details on Ongoing Phase 3b Study
JERSEY CITY, N.J. September 21, 2022 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced two presentations on RADICAVA ORS® (edaravone) in amyotrophic lateral sclerosis (ALS) will be shared at the 2022 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, being held in Nashville, Tenn., from September 21-24.
“We look forward to discussing our latest research in ALS with the scientific community at this year’s AANEM meeting, including presentations derived from two Phase 3 trials – one completed and one ongoing – evaluating the long-term use of RADICAVA ORS through 48 weeks of treatment,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “This information provides the ALS community with additional insights into the clinical use of this oral treatment option plus the importance of continued research, and exemplifies our unwavering commitment to advancing therapies for people living with ALS.”
RADICAVA ORS was recently approved by the U.S. Food and Drug Administration (FDA) as an oral suspension form of edaravone that offers the same efficacy as RADICAVA® (edaravone) – an FDA-approved intravenous (IV) treatment shown to slow the loss of physical function in ALS.1 In clinical trials, the most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%) and headache (10%).1 In an open-label study (MT-1186-A01), fatigue was also observed in 7.6% of patients receiving RADICAVA ORS. RADICAVA and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients.1 To learn more about RADICAVA ORS, visit RADICAVA.com.
Poster Presentation Details:
48-week safety results from the global Phase 3 multi-center, open-label clinical trial (MT-1186-A01) of RADICAVA ORS in patients with ALS will be presented, as well as the study design 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.
- 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)
Poster #126; Poster Session 1: Sept. 22, 6:00 p.m. – 6:30 p.m. CDT, and Poster Session 3: Sept. 23, 3:30 p.m. – 4:00 p.m. CDT
- 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)
Poster #127; Poster Session 1: Sept. 22, 6:00 p.m. – 6:30 p.m. CDT, and Poster Session 2: Sept. 23, 9:30 a.m. – 10:00 a.m. CDT
Both the completed A01 and ongoing A02 studies are sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA).
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 ORS and RADICAVA have been used to treat over 7,600 patients, with over one-million days of therapy, and have been prescribed by more than 1,800 HCPs.2
IMPORTANT SAFETY INFORMATION
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.
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.
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.
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
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/.
- RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
- Data on file. Mitsubishi Tanabe Pharma America, Inc.