Post Hoc Analysis of Phase 3 Data Suggests Edaravone Slows Disease Progression for Amyotrophic Lateral Sclerosis

In post-hoc analysis of data frm the phase 3 clinical trial of edaravone (Radicava, Mitsubishi Tanabe Pharma, New Jersey, NJ), suggests edaravone may have reduced the risk of an exploratory composite of time to death, tracheostomy, permanent assisted ventilation (PAV), and hospitalization. The results are from a post-hoc analysis should be interpreted with caution and are not considered conclusive evidence of efficacy.

"While the phase 3 edaravone study was not designed with survival as an endpoint, this post-hoc analysis allows us to explore insights on the results of early treatment intervention on survival-related events due to ALS progression, including death, hospitalization, ventilation and tracheostomy," said Atsushi Fujimoto, president, MTPA. "We are committed to putting patients first in everything we do, which includes working to explore our phase 3 data in order to help expand understanding."

Over the placebo-controlled 24-week period and an additional 24-week open-label period were 2 deaths among those who had edaravone for 48 weeks vs 4 deaths among those who had placebo for 24 weeks followed by edaravone for 24 weeks. For the cumulative occurrence of milestone events, 53% 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.

"I'm encouraged by the findings of this post-hoc analysis," said Benjamin Rix Brooks, M.D., an ALS specialist and lead author of the study. "We were able to uncover data that reinforces the need to further our research that can show an important association between edaravone use and the potential decrease in functional decline."

The most common adverse events of edaravone include bruising, problems walking, and headache.