Mitsubishi Tanabe Pharma Corporation has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) 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 June 16, 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.
"This is an important milestone for Mitsubishi Tanabe Pharma and for the U.S. ALS community," said Joseph M. Palumbo, MD, Vice President, Head of Clinical Research, Mitsubishi Tanabe Pharma Development America, Inc. "There is an urgent need for new treatment options in ALS and we are now an important step closer to potentially making that a reality. We look forward to working with the FDA as part of the review process."