Edaravone previously granted Orphan Drug Designation by the FDA for amyotrophic lateral sclerosis.
A New Drug Application (NDA) was recently submitted to the FDA for edaravone (MCI-186) in the treatment of amyotrophic lateral sclerosis (ALS).
The NDA submission is Mitsubishi Tanabe Pharma Corporation’s (MTPC) first step in accelerating its US business activities as part of their Medium-Term Management Plan 16-20: Open up the Future, the company noted in a press release.
Thus far, MTPC has established MT Pharma America, Inc to commercialize approved drug products in the United States as a part of their management plan, with future goals to expand its product line by collaborating with partners.
“There is an urgent need for new treatment approaches that may affect the course of this devastating disorder,” said Lucie Bruijn, PhD, MBA, Chief Scientist at The ALS Association. “The ALS Association is encouraged by the efforts of Mitsubishi Tanabe Pharma to make this drug available to people living with ALS in the US.”
In 2015, edaravone was approved to treat ALS in Japan and South Korea and was also granted Orphan Drug Designation by the FDA and European Commission.