General Information

Radicava (edaravone) is a free radical scavenger.

Radicava is specifically indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Radicava is supplied as an infusion for intravenous administration. The recommended dosage of Radicava is an intravenous infusion of 60 mg administered over a 60-minute period according to the following schedule:

An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period

Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods

Clinical Results

FDA Approval

The FDA approval of Radicava was based on a 6-month, randomized, placebocontrolled, double-blind study conducted in Japanese patients with ALS who were living independently and met the following criteria at screening:

Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R; described below])

Normal respiratory function (defined as percent-predicted forced vital capacity values of [%FVC] ≥ 80%)

Definite or Probable ALS based on El Escorial revised criteria

Disease duration of 2 years or less

The study enrolled 69 patients in the Radicava arm and 68 in the placebo arm. Radicava was administered as an intravenous infusion of 60 mg given over a 60 minute period according to the following schedule: An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period (Cycle 1). Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods (Cycles 2-6). The primary efficacy endpoint was a comparison of the change between treatment arms in the ALSFRS-R total scores from baseline to Week 24. Data demonstrated patients who received Radicava for six months experienced significantly less decline in physical function—by 33 percent.

Mechanism of Action

Radicava (edaravone) is a free radical scavenger. It is believed to relieve effects of oxidative stress, a likely key factor in the onset and progression of ALS. Oxidative stress is thought to be an imbalance between the production of free radicals (unpaired, reactive electrons) and the ability of the body to counteract or detoxify their harmful effects. In patients with ALS, there are consistent increases in oxidative stress biomarkers.