Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced three presentations at the 2024 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting being held in Savannah, GA, October 15-18. The presentations will feature amyotrophic lateral sclerosis (ALS) research, including findings from the Phase 3b study (MT-1186-A02), which evaluated the superiority of daily dosing of RADICAVA ORS® (edaravone) compared to the FDA-approved on/off regimen, as well as preclinical data on the effect of edaravone on spinal motor neurons derived from an ALS patient harboring a TDP-43 mutation.
Presentations include final results from the global, multi-center, double-blind, Phase 3b MT-1186-A02 study, which assessed the superiority of daily dosing of RADICAVA ORS compared to the standard FDA-approved on/off regimen. The study confirmed that daily dosing of oral edaravone showed no significant difference and did not demonstrate superiority, further supporting the suitability of the FDA-approved regimen. Additionally, findings from the open-label, multi-center Phase 3 extension study MT-1186-A03 will be shared, evaluating the long-term safety of RADICAVA ORS over a 96 week-period in patients who previously completed the initial 48-week study (MT-1186-A01).
