Mitsubishi Tanabe Pharma America Announces Enrollment Completion for Global, Phase 3b Study of RADICAVA ORS® (edaravone) in ALS
JERSEY CITY, N.J., March 23, 2023 /PRNewswire/ -- 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)
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
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
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.
For more information, including full Prescribing Information, please visit www.RADICAVA.com.
About Mitsubishi Tanabe Pharma America, Inc.
About Mitsubishi Tanabe Pharma Development America, Inc.
About Mitsubishi Tanabe Pharma Corporation
1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
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SOURCE Mitsubishi Tanabe Pharma America, Inc.