Shots:

• The NDA is based on the P-III (RADICAVA IV) trial evaluating the safety & tolerability of edaravone vs Radicava IV formulation in 185 patients with ALS along with 7 P-I clinical pharmacology studies to evaluate PK, safety, drug-drug interactions, dosing, bioavailability & bioequivalence in ALS patients with/out PEG/NGT
• Additionally, edaravone has been developed to have a similar clinical profile compared to the IV formulation of Radicava (edaravone)
• The US FDA has accepted the application for priority review with an anticipated PDUFA date of May 12, 2022. Edaravone is an investigational oral formulation & received the US FDA’s approval for the treatment of ALS in May 2017

Ref: PR Newswire | Image: PR Newswire