FDA Approves Second Medication to Treat ALS
The Food and Drug Administration announced Friday that it has approved a new drug to help treat amyotrophic lateral sclerosis, commonly known as ALS or Lou Gehrig's disease.
The agency said it has approved the drug Radicava, or edaravone, the first new drug approved to treat ALS in 22 years. The only other drug specifically used to treat ALS is riluole, which was approved in 1995.
"After learning about the use of edaravone to treat ALS in Japan, we quickly engaged with the drug developer on filing a marketing application in the US ", Eric Bastings, MD, deputy director of the Division of Neurological Products in The Center for Pharmaceutical Evaluation and Research of the FDA said.
"This is the first new FDA-approved treatment for ALS for many years, and we are delighted that people with ALS have an additional option."
The new drug is administered intravenously with two weeks of daily treatment and a two week break. Tests in more than 100 patients have shown that the drug slows down some of the effects of the disease, which eventually paralyzes the patients. Sickness always leads to death and there is no cure.
Centers for Disease Control and Prevention estimate that about 12,000 to 15,000 Americans suffer from the disease. Most people die from respiratory insufficiency caused by ALS.
However, the drug comes at a price. Mitsubishi Tanabe Pharma Corporation told The New York Times that it would cost $ 145,524 a year. The company stated that it would provide co-payment assistance.
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