FDA Approves Second Drug To Treat ALS, Radicava

A second drug has been approved by the US Food and Drug Administration to treat ALS, also known as Lou Gehrig’s disease.

The agency said it approved the drug Radicava, or edaravone, after studies conducted in Japan. The drug must be given by intravenous infusion and will cost $145,524 a year, according to its manufacturer, MT Pharma America, a subsidiary of the Japanese company Mitsubishi Tanabe Pharma Corporation.

This is only the second drug approved for ALS treatment. The first drug, riluole, was approved in 1995. It has proven to extend survival from the degenerative disease by two or three months.

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said.

“This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”

ALS kills nerve cells that control voluntary muscles, so patients gradually weaken and become paralyzed. Most die within three to five years, usually from respiratory failure. About 12,000 to 15,000 people in the United States have the disease, according to the Centers for Disease Control and Prevention.