, /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of final results from the global, multi-center, double-blind, Phase MT-1186-A02 study of oral edaravone in amyotrophic lateral sclerosis (ALS). Final results showed the daily dosing regimen of RADICAVA ORS (edaravone) did not show superiority to the U.
S. Food and Drug Administration (FDA) approved on/off dosing regimen based on the primary endpoint of Combined Assessment of Function and Survival (CAFS) at 48 weeks. Both dosing regimens provided comparable change in ALSFRS-R from baseline to week 48.
These findings suggest that the current on/off regimen of RADICAVA ORS is the most appropriate regimen for people living with ALS based on efficacy and safety findings from studies MT-1186-A02 and MCI186-19. ALSFRS-R changes observed at week 48 in Study MT-1186-A02 of RADICAVA ORS were similar to the post hoc assessment of the previous Japanese, Phase 3 Study MCI186-19 of intravenous (IV) RADICAVA (edaravone). The MT-1186-A02 study found no new safety concerns and reinforces edaravone as a safe product.
The full results are included in a poster presentation at the European Network for a Cure for ALS (ENCALS) 2024 meeting taking place in . "The safety and efficacy of the on/off dosing regimen of oral edaravone in this Phase post-marketing study was similar to the safety and efficacy of oral edaravone," said , M.D.
, Vice President of Medical Affairs at MTPA. "We extend our gratitude to t.
