ALS Texas

Frequently Asked Questions about Radicava™ (Edaravone)

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Based on information as of 5/5/2017

What is Radicava?

Radicava™ (edaravone) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat people with amyotrophic lateral sclerosis (ALS).1

In clinical trials, some people given Radicava showed significantly less decline in physical function compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in patients with ALS.1,2

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FDA Approves New ALS Drug

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Radicava is First Approved Treatment for ALS in Decades

The Food and Drug Administration’s (FDA) announced 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. The only other approved treatment specifically for ALS, riluzole, was approved in 1995.

“We thank the FDA and MT Pharma 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.”

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FDA Approval Sought for New ALS Drug

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Pharmaceutical company Mitsubishi Tanabe Pharma Corporation submitted a formal proposal to the United States Food and Drug Administration for approval of a drug to treat ALS. The drug, Edaravone, gets rid of toxic waste that is a normal by-product of cell function. It is thought that this waste is not as effectively removed in ALS patients, causing damage to motor neurons, which are the cells that die in ALS patients. Edaravone would protect these neurons by helping rid the cells of this waste.

The Edaravone new drug application is supported by clinical research with ALS patients in Japan, and in 2015, Edaravone was approved as a treatment for ALS in Japan and South Korea. After being submitted to the FDA for consideration, it could either be automatically approved for use in the U.S., or it could require a Phase III study conducted in the U.S.

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