FDA Approves Edaravone as a Treatment for ALS in the US

Now, FDA approved. Clinicians originally developed edaravone as a treatment for stroke. The drug is thought to reduce oxidative stress in cells by lowering levels of free radicals that can damage them (Abe et al, 1988). Regulators approved edaravone for the treatment of stroke in Japan in 2001.

The Federal Drug Administration (FDA) approved edaravone (MCI-186) on May 5 as a treatment for amyotrophic lateral sclerosis (ALS) in the United States. The decision is based on a six month phase 3 clinical trial, known as “study 19”, in Japan which found that edaravone reduced functional decline by 2.49 ALS-FRS-R points over six months compared to placebo in a subset of people recently diagnosed with the disease (see January 2016 news). Edaravone, which is to be marketed under the name Radicava, is expected to be available in the United States by August 2017. Edaravone is also approved for the treatment of ALS in Japan and South Korea.

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Check out our website later this week to read our article featuring reaction to the FDA decision. In the meantime, check out this feature to learn more about edaravone, including “study 19.”

Further Reading

Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. [PubMed].

Abe K, Yuki S, Kogure K. Strong attenuation of ischemic and postischemic brain edema in rats by a novel free radical scavenger. Stroke. 1988 Apr;19(4):480-5. [PubMed].

For people with ALS and their families, check out this Radicava FAQ.

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