The Food and Drug Administration on Friday [May 5, 2017] approved Mitsubishi Tanabe Pharma Corp’s 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, has been sold by Japan-based Mitsubishi Tanabe in Japan and South Korea since 2015.
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 Mitsubishi Tanabe’s U.S. unit MT Pharma America Inc (MTPA), said.
The rare progressive condition attacks nerve cells located in the brain and spinal cord responsible for controlling voluntary muscles.
Another promising drug for ALS is being developed by French drugmaker AB Science SA (ABS.PA), which in March reported positive late-stage data on its drug, masitinib. The drug is now under European review.
The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: FDA Approves New Drug to Treat ALS