NDA for Potential ALS Treatment Submitted to FDA
Mitsubishi Tanabe Pharma announced that a New Drug Application has been submitted to the Food and Drug Administration (FDA) for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis (ALS).
The NDA submission was based on data from a clinical research program in patients with ALS in Japan. Edaravone is currently approved for the treatment of ALS in Japan and South Korea but is not approved by the FDA for any use in the US.
Edaravone is a free radical scavenger believed to relieve the effects of oxidative stress, a likely factor in the onset and progression of ALS.
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