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On May 5, 2017, the FDA granted approval of Radicava (edaravone) for treatment of patients with amyotrophic lateral sclerosis (ALS). The approval is based on a phase III, double-blind, placebo-controlled 24-week trial (MCI 186-19 trial; NCT01492686 at http://clinicaltrials.gov). The trial was restricted to Japanese ALS patients with disease duration <2 years, forced vital capacity ≥80%, and ALS Functional Rating Scale–Revised (ALSFRS-R) score ≥24 points. Researchers randomized 137 patients to either placebo (68 patients) or 60 mg edaravone (69 patients) infused intravenously daily for 14 days, followed by 14 days drug-free; subsequent treatment cycles were 10 daily infusions out of 14 days, followed by 14 days drug-free, for up to 6 cycles.…