19Oct 2023
US FDA approves Ardelyx's kidney disease-related drug

US FDA approves Ardelyx's kidney disease-related drug

The U.S. Food and Drug Administration (FDA) has approved Ardelyx's Xphozah, a drug to treat high phosphate levels in chronic kidney disease patients. This approval follows a previous rejection, and the drug is aimed at addressing hyperphosphatemia, a condition causing elevated phosphorus levels, leading to issues like brittle bones, joint pain, and itchy skin. Intended for patients unresponsive to standard phosphate binder therapies. Initially rejected due to unclear treatment benefits, Xphozah gained favor following an advisory panel's recommendation for its approval, either as a standalone therapy or in combination with existing treatments for dialysis patients. It belongs to the phosphate absorption inhibitor class, targeting a gut protein responsible for phosphorus absorption.

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