Mitsubishi Tanabe Pharma America Announces Update on Global, Phase 3b MT-1186-A02 Postmarketing Study of Oral Edaravone in ALS

Independent data monitoring committee advises conclusion of study evaluating once-daily dosing of oral edaravone following interim futility analysis

JERSEY CITY, N.J. July 31, 2023 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the decision to discontinue the global, multi-center, double-blind, Phase 3b MT-1186-A02 study of oral edaravone in amyotrophic lateral sclerosis (ALS), based on results of a pre-planned futility analysis conducted by an independent data monitoring committee (IDMC) composed of external experts. The IDMC’s recommendation to conclude the study was not based on safety or efficacy concerns, and this decision does not impact the commercial availability of the U.S. Food and Drug Administration (FDA)-approved RADICAVA ORS^® (edaravone).