Ardelyx (ARDX) Announces 9:4 FDA Vote AdCom Vote Favoring XPHOZAH
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Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialys
November 16, 2022 6:29 PM ESTThe Advisory Committee voted 9:4 in favor of XPHOZAH as a monotherapy and 10:2 in favor of XPHOZAH in combination with phosphate binders
The Office of New Drugs is expected to provide a response to Ardelyx's appeal within thirty (30) days
If approved, XPHOZAH will be the first and only phosphate absorption inhibitor, reducing serum phosphorus with one pill taken twice daily
Conference call to be held tomorrow, November 17, 2022, at 8:00 AM ET
WALTHAM, Mass., Nov. 16,... More
