New drug application for MCI 186 (edaravone) is filed at FDA to treat ALS.- Mitsubishi Tanabe.

Mitsubishi Tanabe has announced that a New Drug Application (NDA) has been submitted to the FDA for edaravone (MCI 186) for the treatment of amyotrophic lateral sclerosis (ALS). As many as 30 000 Americans may be affected by ALS with more than 5000 diagnosed annually. The drug has Orphan designation in the US and EU.

Comment: Mitsubishi Tanabe Pharma presented results from a Phase III study of MCI 186 (edaravone) in amyotrophic lateral sclerosis at the 68th Annual Meeting of the American Academy of Neurology. The MCI186-19 study met its primary efficacy endpoint of mean change in the ALS Functional Rating Scale-Revised (ALSFRS-R) at 24 weeks with a frequency of adverse events similar to placebo.