FDA accepts NDA from Mitsubishi Tanabe for edaravone (MCI-186) to treat amyotrophic lateral sclerosis.
The FDA has accepted the New Drug Application (NDA) from Mitsubishi Tanabe for edaravone (MCI-186) an intravenous treatment for amyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease. A decision on the application is anticipated on 16 June , 2017 based on the Prescription Drug User Fee Act. If approved, the medicine will be commercialized, under the brand name Radicava through the newly-formed MT Pharma America, Inc.
Comment: If approved Radicava will be the first ALS treatment to reach the U.S. market since Sanofi's Rilutek (riluzole) in 1995.
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