The first new drug approved specifically to treat amyotrophic lateral sclerosis (ALS), commonly referred to a Lou Gehrig’s Disease, in over two decades was approved in less than a year, thanks in large part to the FDA working in conjunction with Mitsubishi Tanabe Pharma Corp. and the ALS Association.
ALS is a neurodegenerative disease that results in decreased ability to move and control muscles and often leads to paralysis and death within two to five years of diagnosis. Although the reasons are unknown, military veterans are twice as likely to develop ALS as the general population.
Radicava (edaravone) is the first ALS drug to be approved specifically for treatment of the disease since riluzole was approved in 1995. Edaravone was approved in 2015 in Japan to treat stroke, but was later approved for treatment of ALS in both Japan and South Korea. The approval of the drug in the United States provides hope for patients as the drug has slowed the decline of physical function in ALS patients by up to 33 percent.
The ALS Association, the only national nonprofit group dedicated to the research and treatment of the disease, has provided additional information about Radicava on its website.