FDA Gives Green Light to Ardelyx's Kidney Disease Drug
The US Food and Drug Administration (FDA) has approved Ardelyx's drug, Xphozah, to treat high phosphate levels in patients with chronic kidney disease (CKD). Xphozah is a phosphate absorption inhibitor that targets a protein in the gut responsible for phosphorus absorption. The drug is approved for use in patients who have had an inadequate response or intolerance to phosphate binder therapies. Excess phosphorus can lead to complications such as brittle bones, joint pain, muscle cramps, and itchy skin. Ardelyx expects to make the drug available in November and has amended its debt financing agreement to access an additional $50 million to support the commercial launch.