The Food and Drug Administration approved a treatment for ALS, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, on Friday, making it the first U.S. regulatory approval in more than two decades, Reuters reported. Known chemically as edaravone, the drug has been on the market in Japan and South Korea since 2015.
It's a milestone in the name of medicine. The other approved ALS medicine only modestly slows the progression of the disease in some people.
After six months of treatment with the new treatment data showed that edaravone reduced the rate of functional decline in patients by about a third Dr Jean Hubble, VP of medical affairs, at Mitsubishi Tanabe's U.S. unit MT Pharma America Inc (MTPA), said.
The rare disease gained attention in 2014 with the "Ice Bucket Challenge," in which people shared videos of them dumping ice cold water over their heads.
ALS, which is also known as Lou Gehrig's disease in tribute of the New York Yankees player who resigned from baseball after being diagnosed with the disease in 1939, also affects renowned scientist Stephen Hawking. It affects about 6,000 people in the U.S.
The drug is expected to be sold under the brand name Radicava in August. The drug is pricey, however, coming in at nearly $1,1100 per infusion. If taken annually for 12 months or 13 cycles, the cost before the government discount would be $145,524.