The ALS Association, the only national nonprofit fighting amyotrophic lateral sclerosis (ALS) on every front, applauded the Food and Drug Administration’s (FDA) announcement today 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.
“We thank the FDA and MT Pharma for working together to expedite the approval of the first new ALS-specific treatment in decades,” said Barbara Newhouse, president and CEO of The ALS Association. “We hope today’s announcement signals the beginning of a new chapter in the fight against this terrible disease. There are several drugs to treat ALS currently in clinical trials and we are hopeful that people living with ALS have even more therapies available to them sooner rather than later.”
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.