US FDA approves Ardelyx's kidney disease-related drug

[October 18, 2023]  (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.

In a separate statement, Ardelyx said it has amended its 2022 debt financing agreement with investment affiliates managed by SLR Capital Partners (SLR) to access an additional $50 million, which could be further increased by $50 million.

Ardelyx said it expects to draw the second tranche of this debt financing in October to support the commercial launch of Xphozah.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The U.S. health regulator had declined approval for Xphozah, chemically known as tenapanor, in 2021, citing unclear treatment benefits. It reconsidered and called an advisory panel meeting following the company's appeal.

The FDA's outside advisers, however, recommended Xphozah's approval last year as a single therapy or alongside existing treatment for treating high blood phosphate levels in dialysis patients.

Xphozah belongs to a class of drugs called phosphate absorption inhibitor that targets a protein in the gut responsible for the absorption of phosphorus.

(Reporting by Kanjyik Ghosh, Mariam Sunny, Khushi Mandowara and Leroy Leo in Bengaluru; Editing by Shinjini Ganguli, Devika Syamnath and Subhranshu Sahu)

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