Radicava attains FDA approval for ALS treatment

Service care specialists are available to assist patients in finding the closest infusion facility.
Service care specialists are available to assist patients in finding the closest infusion facility. | Contributed photo

Mitsubishi Tanabe Pharma America Inc. of New Jersey has reported that Radicava (edaravone), an intravenous therapy for adults with amyotrophic lateral sclerosis (ALS), is now available in the U.S.

This product represents the first ALS treatment approved by the U.S. Food and Drug Administration in over 20 years. Company spokespersons reported that Radicava can slow down the rate of physical decline in ALS patients by up to 33 percent.

"After 13 years of clinical research and investment, we have reached a seminal moment, which may shift the treatment paradigm for this terrible disease," Tom Larson, chief commercial officer for Mitsubishi Tanabe Pharma America, said. "As of today, all across the country, conversations between ALS specialists and patients may be substantially different. We are all extremely proud and excited to be a part of bringing Radicava and new hope to patients in the U.S."

Because the treatment is intravenous, service care specialists are available to assist patients in finding the closest infusion facility and coordinate insurance benefits.

ALS, also known as Lou Gehrig's disease, affects approximately 5,000 to 6,000 U.S. residents yearly. Most patients die within two to five years of diagnosis.

Want to get notified whenever we write about U.S. Food and Drug Administration (FDA) ?
Next time we write about U.S. Food and Drug Administration (FDA), we'll email you a link to the story. You may edit your settings or unsubscribe at any time.
Organizations in this story

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD - 20903