JERSEY CITY, N.J., March 23, 2023- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced it has completed enrollment for the global, multi-center, double-blind, Phase 3b study (MT-1186-A02) evaluating the long-term efficacy and safety of two dosing regimens of RADICAVA ORS (edaravone) in people with amyotrophic lateral sclerosis (ALS) over 48 weeks. This study is the postmarketing commitment following the U.S. Food and Drug Administration (FDA) approval of intravenous (IV) RADICAVA® (edaravone). Topline results of the study are anticipated in 2024.
“We’re very pleased to announce the completion of trial enrollment in our Phase 3b study of RADICAVA ORS, representing an important achievement in our ongoing commitment to the fight against ALS,” said Atsushi Fujimoto, President, MTPA. “We are deeply grateful to the study participants and their families, as well as study investigators and clinical staff for working so diligently to help us meet this milestone.”
Study MT-1186-A02, which enrolled 384 people with ALS across 80 sites in the U.S., Canada, Europe and Asia, will compare two dosing regimens for RADICAVA ORS over 48 weeks of treatment. After a screening period of eight weeks, study participants (18 to 75 years of age) will receive RADICAVA ORS either once-daily or following the FDA-approved on/off dosing regimen administered in 28-day cycles.1 The primary endpoint will measure change in ALS Functional Rating Scale-Revised (ALSFRS-R) score from baseline to Week 48 of treatment.
Key secondary endpoints for the study include the change from baseline in percent-predicted slow vital capacity (SVC) and the change from baseline in the ALS Assessment Questionnaire (ALSAQ-40) at 48 weeks, as well as the time to death, tracheostomy or permanent assisted mechanical ventilation. Other secondary endpoints include the change from screening and baseline in percent-predicted forced vital capacity (FVC) at 24 and 48 weeks.
“We look forward to seeing how the results of this study evaluating an alternative dosing regimen for RADICAVA ORS build upon our existing data to support its long-term efficacy and safety profile for people living with ALS, and how it may increase our understanding of the full potential of the medication as a treatment option,” said primary investigator Michael D. Weiss, M.D., FAAN, University of Washington Medical Center.
In prior clinical trials for RADICAVA, the most common adverse events (AEs) reported in participants were contusion (15%), gait disturbance (13%) and headache (10%).1 In the pivotal safety trial for RADICAVA ORS, the most common AEs reported at 24 weeks in participants were muscular weakness (16.2%), fall (15.7%) and fatigue (7.6%). RADICAVA and RADICAVA ORS are contraindicated in people with a history of hypersensitivity to edaravone or any of the inactive ingredients.1 See Important Safety Information below. Safety and efficacy data from Study MT-1186-A02 have not yet been analyzed.
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
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.
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.
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.
Posted: March 2023
Radicava ORS (edaravone) FDA Approval History