(Reuters) -The U.S. Food and Drug Administration (FDA) has approved Ardelyx’s drug to treat high phosphate levels in patients with chronic kidney disease (CKD), the company said on Tuesday, more than two years after it was initially rejected.
The drug, branded as Xphozah, was approved to treat hyperphosphatemia, a condition resulting in an abnormally elevated level of phosphorus in the blood.
Excess phosphorus can remove calcium from bones and other parts of the body, which in turn can cause brittle bones, joint pain, muscle cramps and itchy skin.
The FDA has approved the drug for use in patients who have had an inadequate response or intolerance to phosphate binder therapies, the current standard-of-care treatment for the condition.
The company said a commercial launch for the drug is underway, adding that it expects to make the drug available in November.
(Reporting by Kanjyik Ghosh, Mariam Sunny, Khushi Mandowara and Leroy Leo in Bengaluru; Editing by Shinjini Ganguli and Devika Syamnath)
