Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced 48-week results from the global Phase 3 open-label, multi-center clinical trial (MT-1186-A01) assessing the safety and tolerability of RADICAVA ORS® (edaravone) in patients with amyotrophic lateral sclerosis (ALS).
| Data Presented at the European Network to Cure ALS (ENCALS) Meeting 2022 JERSEY CITY, N.J., June 1, 2022 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced 48-week results from the global Phase 3 open-label, multi-center clinical trial (MT-1186-A01) assessing the safety and tolerability of RADICAVA ORS® (edaravone) in patients with amyotrophic lateral sclerosis (ALS). Details about the findings will be presented at the European Network to Cure ALS (ENCALS) Meeting 2022, being held in Edinburgh, Scotland, from June 1-3.
“We are pleased to present the 48-week safety results, which build upon the 24-week results from the global Phase 3 trial that showed a favorable safety profile to support the approval of RADICAVA ORS,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “Patients are the primary focus of our work as we try to make a difference, and we strongly believe in the potential of the oral formulation of edaravone to help people with ALS.” RADICAVA ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022, as an oral treatment for ALS.1 The FDA approval of RADICAVA ORS was supported by several studies, including 24-week results from the global Phase 3 trial (MT-1186-A01) demonstrating the safety and tolerability profile of the treatment in 185 ALS patients (aged ≥18 years to 75 years) across 50 sites in the U.S., Canada, Europe and Japan.2 According to the 48-week results presented at ENCALS, treatment-emergent adverse events (TEAEs) reported by ≥10% of patients were fall (22.2%), muscular weakness (21.1%), constipation (17.8%), dyspnea (10.8%), dysphagia (10.3%) and back pain (10.3%). No serious TEAEs considered to be treatment-related by investigators were reported. Sixteen subjects (8.6%) discontinued the study due to TEAEs. The most common TEAEs leading to discontinuation were respiratory failure, muscular weakness and pneumonia, consistent with the disease state. There were 12 deaths during the 48-week study period, and none of the deaths were related to the study drug (respiratory failure, worsening of ALS, pneumonia, acute respiratory failure, lung disorder, diabetic ketoacidosis, feeding disorder and suicide). “I’m encouraged by the findings from the Phase 3 trial, which provide important information on the safety and tolerability of this new formulation of edaravone in patients with ALS,” said Gary L. Pattee, M.D., a neurologist and ALS specialist based in Lincoln, Neb. “These data reinforce the potential significance of RADICAVA ORS and its important role in the treatment of this devastating disease.” In addition, the loss of physical function was evaluated as an Exploratory Endpoint and measured by the ALS Functional Rating Scale–Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disease in patients with ALS.3 The changes from baseline to all post-baseline visits until Week 48 in ALSFRS-R score were estimated using a mixed model for repeated measures (MMRM) analysis from 139 subjects who completed the study. At the beginning of the study, patients had an average ALSFRS-R score of 40 (SD 4.5). At Week 48, the average change from baseline in ALSFRS-R score was −11.3 (95% CI −12.6, −10.1). Additionally, a separate presentation at the ENCALS meeting will highlight the design of an ongoing Phase 3 open-label extension study (MT-1186-A03) that is evaluating the long-term safety and tolerability profile of RADICAVA ORS for up to 96 weeks. Both the A01 and A03 studies are conducted by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA). Poster Presentation Details:
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, 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 has been used to treat over 6,500 patients, with nearly one-million days of therapy, and has been prescribed by more than 1,600 HCPs.4 IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions 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 Adverse Reactions Pregnancy 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 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 Media inquiries: 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
SOURCE Mitsubishi Tanabe Pharma America, Inc. |
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