The ALS Association, the only national nonprofit fighting amyotrophic lateral sclerosis (ALS) on every front, applauded the Food and Drug Administration’s (FDA) announcement Friday that it has approved Radicava (edaravone), the first new treatment approved specifically for ALS in 22 years. The FDA approved Radicava less than a year after Mitsubishi Tanabe Pharma Corporation submitted a New Drug Application. The only other approved treatment specifically for ALS, riluzole, was approved in 1995.
“It is unprecedented that the FDA has approved a treatment without clinical trials conducted in the U.S., this saved years in the approval process,” said Kim Hanna, President and CEO of The ALS Association Florida Chapter. “We are so thankful to all those involved who made this possible. This announcement is hopefully just the beginning of viable treatments for people fighting this terrible disease.”
ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. For unknown reasons, veterans are twice as likely to develop ALS as the general population.
Edaravone was originally approved in Japan to treat stroke and in 2015, it was approved for use as a treatment for ALS in Japan and South Korea. In the United States, it will be commercialized under the brand name radicava. According to MT Pharma, the drug has been demonstrated to slow decline of physical function in ALS patients by 33 percent.