New RADICAVA® Findings Presented By Mitsubishi Tanabe Pharma At ENCALS 2024

Mitsubishi Tanabe Pharma America, Inc. (MTPA) reported findings from two RADICAVA® (edaravone) studies for amyotrophic lateral sclerosis (ALS) at the 2024 ENCALS meeting. One ongoing real-world study, using data from the ALS/MND Natural History Study Consortium, indicated that ALS patients starting RADICAVA alongside riluzole experienced an additional survival benefit of 3.2 months compared to those treated with riluzole alone. Additionally, results from Study MT-1186-A03 (NCT04577404), a Phase 3 trial assessing the long-term safety of RADICAVA ORS®, revealed no new safety issues and demonstrated good tolerability over 96 weeks.

Gustavo A. Suarez Zambrano, Vice President of Medical Affairs at MTPA, said "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. 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 assessed how RADICAVA treatment affects ALS patients' treatment patterns, clinical results, and survival using data from the ALS/MND NHC database. Participants who received RADICAVA with or without riluzole (n=176) were compared with a group receiving only riluzole (n=176), matched based on various factors, including their initial ALS Functional Rating Scale-Revised score (39.5±4.8 and 39.3±4.8, respectively). The safety of RADICAVA ORS was confirmed in a 6-month Phase 3 clinical trial involving 185 patients.

RMST or Restricted mean survival time analyses spanning 50 months indicated that individuals treated with RADICAVA ± riluzole survived for an average of 31.1 months. On the other hand, those treated with riluzole alone survived for 28.8 months, with no baseline covariate adjustments. After adjusting for covariates, the RMST difference between the treatment groups was 3.2 months (p<0.03).

Alex Sherman, Director of the Center for Innovation & Biomedical Informatics (CIB) at the NCRI at MGH and Principal Investigator for the study, said in a statement, "Through our collaboration with MTPA, we are thrilled to highlight initial results from a real-world analysis of people living with ALS in our database. 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."