FDA Panel Recommends Ardelyx’s CKD Drug

An FDA advisory committee voted 9-4 in favor of Ardelyx’s Xphozah (tenapanor) for adults with chronic kidney disease (CKD) who are on dialysis, despite some concerns over the drug’s efficacy.

Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended the drug as a monotherapy for the condition — opining that though the degree of clinical benefit was not entirely known at present it offered some benefit in lowering serum phosphorous in addition to addressing a significant unmet need.

The committee also endorsed the drug in combination with phosphate binders for controlling serum phosphorous levels, in a 10-2 vote with one abstention.