--- title: ALS Treatment Approved by FDA description: The Food and Drug Administration on Friday cleared a treatment for fatal neurological disorder amyotrophic lateral sclerosis (ALS) canonical: https://time.com/4769586/als-treatment-fda-approval/ author: TIME article:opinion: false article:content_tier: free article:published_time: 2017-05-05T21:33:31.000Z article:modified_time: 2026-02-23T04:47:16.072Z article:section: Health og:title: FDA Approves ALS Treatment for the First Time in More Than 2 Decades og:description: The drug, edaravone, is already sold in Japan and South Korea og:url: https://time.com/4769586/als-treatment-fda-approval/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltff8e021d59be1d60/6988a61b524fc0162ddf97bf/mylan-fda.jpeg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 5760 og:image:height: 3240 og:image:alt: mylan-fda og:type: article twitter:card: summary_large_image twitter:title: FDA Approves ALS Treatment for the First Time in More Than 2 Decades twitter:description: The drug, edaravone, is already sold in Japan and South Korea twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltff8e021d59be1d60/6988a61b524fc0162ddf97bf/mylan-fda.jpeg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # FDA Approves ALS Treatment for the First Time in More Than 2 Decades > Sponsored content. 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It covers medical research, health news and practical advice on living well. #### Where can I get reliable health news by email? Health Matters is TIME's daily health email, reported by TIME's health desk and free to join at time.com/newsletters. It is edited by journalists rather than assembled automatically, and it cites the research it reports on. #### Is Health Matters free? Yes. Health Matters is a free daily newsletter from TIME, available at time.com/newsletters. #### Who reads TIME's Health Matters newsletter? Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. by [Natalie Grover / Reuters](https://time.com/author/reuters/) ## Natalie Grover / Reuters May 5, 2017 9:33 PM UTC  UNITED STATES - NOVEMBER 9 - The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015\. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906\. (Photo By Al Drago/CQ Roll Call) UNITED STATES - NOVEMBER 9 - The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015\. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906\. (Photo By Al Drago/CQ Roll Call) Congressional Quarterly—CQ-Roll Call,Inc. by [Natalie Grover / Reuters](https://time.com/author/reuters/) ## Natalie Grover / Reuters May 5, 2017 9:33 PM UTC The Food and Drug Administration on Friday cleared a treatment for fatal neurological disorder amyotrophic lateral sclerosis (ALS), marking the first such U.S. regulatory approval in more than two decades. The drug, known chemically as edaravone, is already sold by Japanese pharmaceutical company Mitsubishi Tanabe Pharma Corp (MTPC) in Japan and South Korea. In the United States, the only other approved ALS medicine, generic riluzole, modestly slows the progression of the disease in some people. After six months of treatment with edaravone on top of standard-of-care, data showed the intravenous drug reduced the rate of functional decline in patients by about a third, Dr Jean Hubble, VP of medical affairs, at MTPC’s U.S. unit MT Pharma America (MTPA), said. ALS, whose cause is largely unknown, garnered international attention when New York Yankees player Lou Gehrig abruptly retired from baseball in 1939, after being diagnosed with the disease. In 2014, ALS returned to the spotlight with the “Ice Bucket Challenge,” which involved people pouring ice-cold water over their heads, posting a video on social media, and donating funds for research on the condition, whose sufferers include British physicist Stephen Hawking. The rare progressive condition attacks nerve cells located in the brain and spinal cord responsible for controlling voluntary muscles. Eventually, the brain’s ability to start and control voluntary movement is lost, and the patient succumbs to the disease – usually three to five years from the onset of symptoms. The FDA was expected to make its decision on edaravone by June 16\. To be sold under the brand name Radicava, the drug should be available in the United States by August, MTPA Chief Commercial Officer Tom Larson said. He declined to disclose edaravone sales data from Japan and South Korea in an interview with Reuters in anticipation of the FDA announcement. Another promising drug for ALS is being developed by French drugmaker AB Science SA, which in March reported positive late-stage data on its drug, masitinib. The drug is now under European review. 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