Research & Development
The US FDA accepts new drug application for investigational oral formulation of Mitsubishi Tanabe Pharma America's edaravone to treat amyotrophic lateral sclerosis
13 January 2022 -

Mitsubishi Tanabe Pharma America Inc., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation's 100% owned United States holding company, Mitsubishi Tanabe Pharma Holdings America Inc, announced on Wednesday that the United States Food and Drug administration (FDA) has accepted the new drug application for an investigational oral formulation of edaravone (MT-1186) to treat amyotrophic lateral sclerosis (ALS).

The US FDA has accepted the application for priority review with a Prescription Drug User Fee Act (PDUFA) action date of 12 May 2022. The FDA grants Priority Review for medicines that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

The comprehensive clinical development program for edaravone in ALS has spanned over a decade and included multiple clinical trials for the IV and the investigational oral formulation. The new drug application is supported by data from the RADICAVA IV pivotal trial and upwards of seven Phase one clinical pharmacology studies evaluating the pharmacokinetics, safety, drug-drug interactions, dosing, bioavailability and bioequivalence of the oral suspension in healthy individuals and ALS patients with and without PEG/NGT, along with a Phase three clinical trial assessing the safety and tolerability of the investigational oral suspension over the course of 24 weeks in patients with ALS. There is an ongoing study evaluating the safety and tolerability of the oral suspension at 48 and 96 weeks.