Phase III edaravone post-hoc analysis of Radicut shows risk reduction in amyotrophic lateral sclerosis.- Mitsubishi Tanabe

Mitsubishi Tanabe Pharma America announced a post-hoc analysis of its Phase III edaravone study reviewing the results of intravenous (IV) Radicut / Radicava (edaravone treatment) on disease progression milestones and events among people with amyotrophic lateral sclerosis (ALS). In the analysis, a risk reduction was observed for the exploratory composite estimate of time to death, tracheostomy, permanent assisted ventilation (PAV), and hospitalization. This post-hoc analysis assessed the double-blind, placebo-controlled 24-week Phase III study of edaravone, including an additional 24-week open-label period with all patients receiving IV edaravone (i.e., edaravone-edaravone [EE] vs. placebo-edaravone [PE] groups). There were no deaths during the double-blind period. During the open-label period, there were two deaths in the EE group and four in the PE group. Survival analysis of the cumulative occurrence of milestone events (death, tracheostomy, PAV and hospitalization due to ALS progression) showed a 53 percent relative risk reduction in the EE group, with a hazard ratio of 0.47. The hazard ratio for death alone was 0.48 for the EE group vs. the PE group. As these results are from a post-hoc analysis, the results should be interpreted with caution and cannot be considered conclusive evidence of efficacy. The data was highlighted as an oral presentation at the 2021 Muscular Dystrophy Association Clinical & Scientific Virtual Conference.