Real-world analysis suggests 3.2-month survival benefit for individuals treated with RADICAVA and riluzole compared to those treated with only riluzole No new safety concerns in final results from long-term Phase 3 safety extension study in RADICAVA ORS
"Access to real-world data is critical for complex rare diseases like ALS, and we are proud to collaborate with the ALS/MND Consortium to bring important real-world insights to the clinical community," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "In addition, we are encouraged that our long-term Phase 3 safety extension study continues to demonstrate the safety and tolerability profile of RADICAVA." The ongoing real-world study evaluated treatment patterns, clinical outcomes, and survival of RADICAVA–treated people living with ALS from the ALS/MND NHC database. Individuals receiving RADICAVA ± riluzole (n=176) were matched to those receiving riluzole only (n=176) based on a variety of factors, including their baseline mean ± standard deviation (SD) ALS Functional Rating Scale-Revised score (39.5±4.8 and 39.3±4.8, respectively). The safety profile of RADICAVA ORS was demonstrated in a 6-month, Phase 3, open-label clinical trial in 185 patients.1 In addition to contusion, gait disturbance, and headache reported with RADICAVA, fatigue was observed in 7.6% (14/185) of patients receiving RADICAVA ORS.1 Please see Important Safety Information below and Full Prescribing Information here. Restricted mean survival time (RMST) analyses over 50 months suggested a survival benefit for individuals receiving RADICAVA ± riluzole (31.1 months) versus those receiving riluzole only (28.8 months), without adjustment for baseline covariates. RMST difference between treatment groups was 3.2 months (pAlex Sherman, Director of the Center for Innovation and Biomedical Informatics (CIB) at the NCRI at MGH and Principal Investigator for the study. "Together, our real-world findings underscore our continued commitment to improving outcomes and building confidence in existing treatment options for the ALS community. We hope to build this momentum as our analysis of treatment patterns in the database continues." Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186- Study MT-1186-A03 was a Phase 3, open-label, multi-center, extension study that evaluated the long-term safety of RADICAVA ORS over an additional 96 weeks in patients who have completed the initial 48 weeks of Study MT-1186-A01. Participants received RADICAVA ORS (105-mg dose) according to the FDA-approved dosing. Patients had definite, probable, probable-laboratory-supported, or possible ALS; baseline forced vital capacity ≥70%; and baseline disease duration ≤3 years. ® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. RADICAVA is administered in 28-day cycles by intravenous (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 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), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), 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 16,000 people with ALS, with over 1.9-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4 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
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. For more information, including full Prescribing Information, please visit www.RADICAVA.com.
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG 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 working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally 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/.