WIKIMEDIA, CALLEAMANECERThe US Food and Drug Administration on Friday (May 5) approved edaravone (Radicava) for the treatment of amyotrophic lateral sclerosis (ALS). The drug, manufactured by MT Pharma America, the US subsidiary of the Japanese company Mitsubishi Tanabe Pharma Corporation, is only the second approved ALS treatment in the U.S. The first, riluzole (Rilutek), was approved in December 1995.
“I’m very happy, frankly, that there is a second drug approved for ALS,” Neil Shneider, director of the Eleanor and Lou Gehrig ALS Center at Columbia University Medical Center, told The New York Times. “The effect is modest but significant.”
“It’s exciting,” agreed Nathan Staff, director of the ALS Clinic at the Mayo Clinic in Rochester, Minnesota, speaking with Forbes. “I expect many, if not all, of our patients will be lining up to try to get the medication.”
Edaravone’s approval was based on a trial of 137 ALS patients in Japan. After six months, patients receiving treatment had deteriorated less than those receiving a placebo. “After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer ...