FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Radicava (edaravone)


Slows the functional decline in patients with amyotrophic lateral sclerosis (ALS).


Pyrazolone free radical scavenger. Although the precise mechanism by which edaravone works in ALS is unknown, it may lessen the effects of oxidative stress, which is thought to be a probable factor in ALS onset and progression.


Initial treatment cycle: Administer 60 mg as an IV infusion over 60 minutes once daily for 14 days, followed by a 14-day drug-free period.

Subsequent treatment cycles: Administer 60 mg as an IV infusion once daily over 60 minutes for 10 of 14 days, followed by a 14-day drug-free period.


Approval was based on a phase 3 trial (MCI186-19), which evaluated 137 people with ALS. Data demonstrated patients who received edaravone for 6 months experienced significantly less decline in physical function (33% reduction or 2.49 ALSFRS-R points; P=0.001).


Tanaka M, et al. A 24-Week, Phase III, Double-Blind, Parallel-Group Study of Edaravone (MCI-186) for Treatment of Amyotrophic Lateral Sclerosis (ALS) (P3.189). Presented at the American Academy of Neurology Annual Meeting. Vancouver, BC. 2016 Apr 18.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.