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News From the Food and Drug Administration
June 20, 2017

Antioxidant Drug Approved for ALS

JAMA. 2017;317(23):2363. doi:10.1001/jama.2017.6974

A drug that was approved 2 years ago in Japan and South Korea for patients with amyotrophic lateral sclerosis (ALS) now is FDA approved for the same indication. Edaravone is the first ALS drug to gain approval since the agency sanctioned riluzole in 1995.

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” Eric Bastings, MD, deputy director of the FDA’s Division of Neurology Products, said in a statement. “[W]e are pleased that people with ALS will now have an additional option.”