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Drug & Device News
FDA Approves Use of Drug to Treat ALS
In a May 5 release, the U.S. Food and Drug Administration (FDA) announced its approval of Radicava (edaravone), a drug already being used in Japan to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. http://bit.ly/2sJUpR8. ALS attacks the nerve cells that control muscles, causing them to become inactive, weak and, eventually, paralyzed. Most ALS sufferers die of respiratory failure within three to five years of the first onset of symptoms.
“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,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.” The medication will be made available in the United States by Mitsubishi Tanabe Pharma America, Inc.
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