US Food and Drug Administration Approves New ALS Drug

On Monday morning, the United States Food and Drug Administration approved a new drug aimed at treating amyotrophic lateral sclerosis, also known as ALS and, more commonly, Lou Gehrig’s disease. This drug is called edaravone, which will be sold under the label Radicava.

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” explains FDA Center for Drug Evaluation and Research deputy director of the Division of Neurology Products, Eric Bastings. “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.”

ALS, of course, is a rare disease which attacks the nerve cells—eventually killing them—which causes the sufferer to lose voluntary muscle control. The voluntary muscle control loss is most characterized in daily actions like walking, chewing, talking, and even breathing. Essentially, the dysfunction occurs in specific muscles or muscle groups, which become weak over time and eventually succumb to paralysis. As such, then, the disease is progressive.

The United States Centers for Disease Control and Prevention estimates somewhere between 12,000 and 15,000 people suffer from ALS in America at any given time. Most of these people will likely, eventually, die of respiratory failure, and typically within three to five years after the onset of the first symptoms.

The drug, Radicava, though, can be helpful. This is an intravenous infusion administered by a health care professional (as opposed to over the counter that you can take at home). The drug is administered with one initial treatment cycle of daily doses for 14 days. This is followed by another 14 day cycle, but without the drug. Additional treatment cycles can consist of daily dosing for 10 of 14 days, followed by another 14-day drug free period.

With this approval, then, the drug has been released with a list price of $1,000 per infusion. That means the average ALS patient could look at paying around $150,000 per year for treatment
The company has estimated that Radicava will likely be available to ALS patients in the United States at some time in August.

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