Mitsubishi Tanabe (MT) Pharma America announced that the Food and Drug Administration (FDA) has approved Radicava (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS). This approval marks the first new treatment for ALS in over 20 years.

The FDA’s decision was supported by data from the clinical development program for Radicava that lasted 13 years with multiple Phase 3 studies. The MCI186-19 study (n=137) evaluated Radicava vs. placebo in patients with ALS. Study patients were randomized to Radicava 60mg intravenously (IV) or placebo during a 6-month double-blind, placebo-controlled phase after an initial 12-week pre-observation period. The primary endpoint was the change in ALSFRS (ALS Functional Rating Scale-Revised) score from baseline to 6 months. 

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The study demonstrated that ALS patients who received Radicava for 6 months had significantly less decline in physical function (33% or 2.49 ALSFRS-R points; P=0.0013). The most common side effects (occurring in >10% of patients) were contusion, gait disturbance, and headache.

Radicava will be available as a 30mg/100mL strength solution in single-dose bags for IV infusion in 1- or 2-count cartons. 

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