January 31, 2023

by Colin Kellaher

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A US Food and Drug Administration advisory committee voted that the benefits of its proposed Xphozah drug for patients with chronic kidney disease outweigh its risks.

The Fremont, California, biopharmaceutical company said the committee voted 9-4 in favor of Xphozah as a monotherapy for the control of serum phosphorus in adults with chronic kidney disease who are on dialysis and 10-2 in favor of the drug in combination with voted in favor of. Phosphate binders.

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The FDA convened the meeting last year in response to an appeal of the drug’s rejection by the agency.

Ardelyx said the FDA’s Office of New Drugs, which was considering the company’s second-level appeal, will consider the panel’s vote when making its decision, with a response expected within 30 days.

The FDA is not bound to follow the advice of its advisory panels, although it usually does.

Trading in Ardelyx stock was halted throughout the day on Wednesday ahead of the meeting. The stock, which ended Tuesday’s session at $1.22, soared 77% to $2.16 in premarket trading as recently as Thursday.

Write to Colin Kellaher at [email protected]

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