Mitsubishi Tanabe Pharma America announced 48-week results from the global Phase 3 open-label, multi-center clinical trial (MT-1186-A01) assessing the safety and tolerability of Radicava ORS (edaravone) in patients with amyotrophic lateral sclerosis (ALS).

"We are pleased to present the 48-week safety results, which build upon the 24-week results from the global Phase 3 trial that showed a favorable safety profile to support the approval of Radicava ORS," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "Patients are the primary focus of our work as we try to make a difference, and we strongly believe in the potential of the oral formulation of edaravone to help people with ALS."

Radicava ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022, as an oral treatment for ALS.1 The FDA approval of RADICAVA ORS was supported by several studies, including 24-week results from the global Phase 3 trial (MT-1186-A01) demonstrating the safety and tolerability profile of the treatment in 185 ALS patients (aged ≥18 years to 75 years) across 50 sites in the U.S., Canada, Europe and Japan.

"I'm encouraged by the findings from the Phase 3 trial, which provide important information on the safety and tolerability of this new formulation of edaravone in patients with ALS," said Gary L. Pattee, M.D., a neurologist and ALS specialist based in Lincoln, Neb. "These data reinforce the potential significance of RADICAVA ORS and its important role in the treatment of this devastating disease."