FDA Approves Edaravone (Radicava) for ALS

May 05, 2017

The US Food and Drug Administration (FDA) today approved the drug edaravone (Radicava, Mitsubishi Tanabe Pharma America) to slow down functional decline in patients with amyotrophic lateral sclerosis (ALS).

Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression.

The drug was first approved to treat ALS in Japan and Korea in 2015. After learning about edaravone's use in Japan, the FDA "rapidly engaged" the manufacturer to apply for approval in the United States, said Eric Bastings, MD, deputy director of the neurology products division in the agency's Center for Drug Evaluation and Research.

"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," Dr Bastings said in a news release.

Edaravone is administered intravenously by a healthcare professional. The first treatment cycle consists of daily doses for 14 days, followed by 14 days with no treatment. In subsequent cycles, a patient receives 10 doses over 14 days and then foregoes the drug over the next 14 days.

The FDA determined that edaravone was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. "At week 24, individuals receiving edaravone declined less on a clinical assessment of daily functioning compared to those receiving a placebo," the agency said.

Hives, swelling, and shortness of breath are serious risks associated with edaravone that require immediate medical care. Another serious risk is an allergic reaction to sodium bisulfite, a drug ingredient that can trigger life-threatening anaphylactic symptoms in people with sulfite sensitivity, according to the FDA.

Bruising and gait disturbance were the most common adverse events reported by participants in the clinical trial.

More information about today's decision is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert

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