Washington, D.C. (May 5, 2017) — 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. There are only two other approved treatments specifically for ALS, Riluzole and Tiglutik.
“We thank the FDA and Mitsubishi Tanabe Pharma America 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 Mitsubishi Tanabe Pharma America, the drug has been demonstrated to slow decline of physical function in ALS patients by 33 percent.
More information about Radicava can be found here.
About The ALS Association
The ALS Association is the only national non-profit organization fighting Lou Gehrig’s Disease on every front. By leading the way in global research, providing assistance for people with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified clinical care centers, and fostering government partnerships, The Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure. For more information about The ALS Association, visit our website at www.als.org.
About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, NJ, Mitsubishi Tanabe Pharma America is a wholly-owned subsidiary of MTPC’s 100% owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. Mitsubishi Tanabe Pharma America is dedicated to delivering innovative solutions that address the unmet medical needs of patients in the United States. It was established by MTPC to commercialize approved pharmaceutical products in the U.S. with plans to expand its product line through collaborations with partners.