FDA approves Radicava (edaravone) for amyotrophic lateral sclerosis- MT Pharma America

MT Pharma America announced the FDA has granted approval of Radicava (edaravone), as an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS). The pivotal Phase III study (MCI186-19), which evaluated 137 people with ALS, formed the basis for the FDA approval of Radicava. People given Radicava showed significantly less decline in physical function compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in patients with ALS.

Data demonstrated patients who received Radicava for six months experienced significantly less decline in physical function � by 33 percent or 2.49 ALSFRS-R points. The most common adverse reactions that occurred in greater than 10 percent of patients and greater than placebo were bruising (contusion), problems walking (gait disturbance) and headache.