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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Radicava (edaravone)

Indication:

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

Mechanism:

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.

Dosage:

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:

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).

Reference:

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.

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