The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for edaravone (MCI-186; Mitsubishi Tanabe) for the treatment of amyotrophic lateral sclerosis (ALS).
The NDA for edaravone is based on data from a clinical research program conducted in ALS patients in Japan. Edaravone is currently not approved for any indication in the U.S, however, it is approved for the treatment of ALS in Japan and South Korea.
The FDA has set a Prescription Drug User Fee Act target date of June 16, 2017 to make a decision on the NDA. If approved, MT Pharma America, a subsidiary of Mitsubishi Tanabe, will commercialize edaravone under the brand name Radicava.
Edaravone is an intravenous, free radical scavenger believed to relieve the effects of oxidative stress, a likely factor in the onset and progression of ALS.
For more information visit MT-pharma-america.com.