Mitsubishi Tanabe Pharma Reports Phase III Results of RADICAVA ORS in ALS

Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced the 48-week results from a global, multi-center, open-label, Phase 3 clinical trial (MT-1186-A01) evaluating the long-term safety and tolerability of RADICAVA ORS (edaravone) in the treatment of amyotrophic lateral sclerosis (ALS).

Data from the study showed that RADICAVA ORS was generally well tolerated during the treatment period, with no new safety signals identified.

“We’re encouraged by the data that we continue to collect from the global Phase 3 trial of RADICAVA ORS, demonstrating a favorable safety profile after 48 weeks of treatment,” said Gustavo Suarez Zambrano, vice president of medical affairs at MTPA. These data build upon the study’s 24-week findings that supported the FDA approval of RADICAVA ORS and underscore our commitment to growing our body of knowledge regarding the use of this treatment in people with ALS.”

RADICAVA ORS was approved by the U.S. FDA on May 12, 2022, as an oral suspension form of edaravone, the active ingredient in RADICAVA (edaravone) – an FDA-approved intravenous (IV) treatment shown to slow the loss of physical function in ALS.

The approval of RADICAVA ORS was supported by several studies, including 24-week results from Study MT-1186-A01 demonstrating the safety and tolerability profile of the treatment in 185 ALS patients. Study MT-1186-A01 enrolled 185 patients with ALS across 50 sites in the in the U.S., Canada, Europe and Japan.