Phase III extension data shows reduction in decline with Radicava (edaravone) in amyotrophic lateral sclerosis - MT Pharma America

MT Pharma America announced open-label extension data that show patients with amyotrophic lateral sclerosis (ALS) treated with Radicava (edaravone) for 48 weeks (12 cycles) experienced significantly less decline in physical function, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), compared with patients given placebo for six months followed by six months of Radicava. In the open-label extension phase of the MCI186-19 study presented at ENCALS, patients received Radicava for an additional 24 weeks.

Patients who received Radicava for the full 48 weeks continued to experience a statistically significant reduction in the rate of decline in physical function, compared to patients given 24 weeks of placebo before switching to 24 weeks of Radicava. Additionally, patients initially given Radicava had approximately 58 percent relative risk reduction in death or certain disease progression events (e.g., loss of upper limb function) compared to those initially given placebo. There were no notable differences in the incidence of adverse events between groups other than contusion. The findings were featured in an oral presentation at the European Network for the Cure of ALS (ENCALS) annual meeting.

Comment: Study MCI186-19 was a pivotal Phase III study that evaluated the efficacy and safety of Radicava compared with placebo in 137 people with ALS. In the study, after a 12-week pre-observation period, eligible patients were randomized 1:1 to receive Radicava 60 mg intravenously for 60 minutes or placebo during a six-month double-blind placebo-controlled phase. The primary endpoint for the study was change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score from baseline to six months.