Mitsubishi Tanabe seeks oral edaravone approval for ALS in Japan

Japanese firm Mitsubishi Tanabe (TYO: 4508) has submitted to the Ministry of Health, Labor and Welfare in Japan an application for the manufacturing and marketing approval of an investigational oral formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS).

MT-1186 is an oral suspension formulation that contains the same active ingredient as edaravone for intravenous infusion, which carries the Japanese product name Radicut Injection 30mg and was first approved in 2015.

This earlier non-oral formulation received regulatory approval in the USA in 2017 and has so far been approved in a total of nine countries globally, also including South Korea, Canada and Switzerland.