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ALS Worldwide
5808 Dawley Drive
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ALS Worldwide
September 01, 2016

RADICAVA™ (edaravone)

Mitsubishi Tanabe Pharma Corporation (MTPC) recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for edaravone (MCI-186), an intravenous treatment for amyotrophic lateral sclerosis (ALS).

Edaravone is a free radical scavenger that is believed to relieve the effects of oxidative stress, a likely factor in the onset and progression of ALS. Oxidative stress is thought to be an imbalance between the production of free radicals and the ability of the body to counteract or detoxify their harmful effects. In patients with ALS, there are consistent increases in oxidative stress biomarkers.

In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. In the same year, the FDA and the European Commission granted Orphan Drug Designation for edaravone. A decision on the application is anticipated on June 16, 2017 based on the Prescription Drug User Fee Act. However, if approved at that time, it may take a minimum of 6 months before it's available at pharmacies. If approved, the medicine will be commercialized, under the brand name RADICAVA™, through the newly-formed MT Pharma America, Inc. 

Over the past year, ALS Worldwide has been closely monitoring the development of edaravone because there is an urgent need for new treatment options for people living with this devastating disease. We hope this promising drug will be effective at slowing the progression of ALS and providing some disease reversal, particularly when used by those who have had the disease for less than three years. 

Having said that, edaravone may provide benefit to all people living with the disease regardless of time of onset, because the clinical research program conducted in Japan only tested the drug on early stage ALS patients. More is not known at this time about its efficacy for long-term patients. 

We will provide updated news about RADICAVA's development as it is made available to us for the benefit of our online community.