The FDA took the unusual step of asking the company to apply for U.S. approval after learning of the drug’s use in Japan for ALS. Photo: Andrew Harnik/Associated PressThe Food and Drug Administration approved the first drug in more than two decades for the treatment of ALS, the paralyzing and fatal malady often called Lou Gehrig’s disease. The clinical study of the drug, done in Japan, involved 137 patients over six months. The drug is given intravenously by health care professionals in dosing for 14 days, followed by 14 days off the drug. Then this is followed by administration of treatment in cycles of 10 in 14 days, followed by 14 days off the drug.

Source: Wall Street Journal May 05, 2017 23:03 UTC