The Food and Drug Administration on Tuesday approved the first drug from an emerging class of medicines for patients with a chronic, autoimmune kidney disease, according to a notice on the agency’s website.
The new drug, called Voyxact, is made by Otsuka, the Japanese pharmaceutical company. U.S. regulators cleared it to treat IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.
“We are excited to make a new treatment option available to nephrologists and their patients,” said John Kraus, Otsuka’s chief medical officer, in an interview with STAT prior to the posting of approval decision.
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