Posted by Michael Wonder on 21 Jun 2016
Mitsubishi Tanabe Pharma submits new drug application for edaravone to treat ALS in the United States
20 June 2016 - Mitsubishi Tanabe Pharma Corporation today announced that a new drug application has been submitted to the U.S. FDA for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis, a rapidly progressive neurological disease.
As many as 30,000 Americans may be affected by amyotrophic lateral scelrosis (ALS) with more than 5,600 diagnosed annually.
The edaravone NDA is supported by a clinical research program in patients diagnosed with ALS in Japan. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. In the same year, the FDA and the European Commission granted Orphan Drug Designation for edaravone. It is not currently approved by the FDA for any use in the U.S.
For more details, go to: http://www.mt-pharma.co.jp/e/release/nr/2016/pdf/e_MTPC160620_RC.pdf
