Once Daily Dosing with Radicava ORS Was Not Superior to On/Off Dosing for the Treatment of People with ALS

Results of a phase 3b extension study presented at the 2024 meeting of the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium demonstrated the non-superiority of daily dosing of oral Radicava ORS (edaravone; Mitsubishi Tanabe Pharma America, Jersey City, NJ) compared with the current Food and Drug Administration (FDA)-approved on/off dosing regimen.

MT-1186-A04, a randomized, double-blind, multi-center, phase 3b extension study (NCT05151471) included participants who were assessed for an additional 48 weeks after completion of the phase 3 MT-1186-A02 study (NCT04569084), in which they were treated with Radicava ORS with either once daily dosing or the FDA-approved on/off dosing regimen. There was no significant difference in ALS Functional Rating Scale-Revised (ALSFRS-R) score reductions in individuals treated with daily dosing of Radicava ORS compared with individuals receiving the FDA-approved on/off dosing. This finding suggests that for Radicava ORS, the FDA-approved on/off dosing regimen is the most appropriate dosing regimen for treating people with ALS.

"We're pleased to share the findings of the Phase 3b extension study and an analysis of long-term function, which highlight additional data about the impact that Radicava ORS can have on function and survival for people living with ALS," said Gustavo A. Suarez Zambrano, MD, Vice President of Medical Affairs at MTPA.