First New ALS Treatment in Decades Approved by FDA

Radicava (edaravone) has been cleared as a therapeutic option for the disease.

It has been more than 20 years since a treatment for ALS has been approved by US regulators, but that changed on May 8 when the FDA announced its approval of Mitsubishi Tanabe Pharma Corp's Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), known commonly as Lou Gehrig’s disease in the US.

After learning that Japanese regulators approved the use of edaravone to treat ALS in Japan, the agency said it quickly reached out to Mitsubishi Tanabe to request they file a marketing application in the US. Eric Bastings, Deputy Director of the FDA’s Center for Drug Evaluation and Research remarked, “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.”

The Centers for Disease Control and Prevention find approximately 12-15,000 people suffer from the disease in the US. According to the FDA, the efficacy of edaravone was demonstrated in a clinical trial involving 137 people randomized to receive the drug or a placebo. By Week 24, patients receiving edaravone exhibited less decline than those receiving the placebo. 


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