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US Food and Drug Administration approves first ALS drug in 22 years

08 May 2017

The US Food and Drug Administration has approved the first new drug for the treatment of amyotrophic lateral sclerosis, or ALS, in over two decades.

The FDA announced on Friday that Radicava, also known as edaravone, had been approved for use in the US. Riluzole was the only other drug approved specifically for the treatment of ALS in the US in 1995.

In tests conducted in Japan, ALS sufferers who received edaravone were found to have a smaller decline in their level of daily functioning as against those were given a placebo. According to MT Pharma, the maker of edaravone, the drug slowed the decline of physical function by 33 per cent.

"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," Eric Bastings, the deputy director of the FDA's neurology products division, said in a statement.

"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, a progressive, neurodegenerative disease, affects the nerve cells in the brain and spinal cord that make muscles work. The cells lose their ability to initiate and control muscle movement, which leads to paralysis and death.

Radicava, manufactured by MT Pharma America, a subsidiary of Mitsubishi Tanabe Pharma Corporation, Japan, is given by intravenous infusion and will cost over $145,000 per year.

Death, usually occurs from respiratory failure in ALS, between three to five years after the symptoms start to appear.

While the approval of a new ALS treatment offered new option for those with the condition, it does not provide a cure for the disease. The condition affects 12,000 to 15,000 US citizens, according to figures from the Centers for Disease Control and Prevention.

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