Dispute Resolved? Ardelyx’s Tenapanor Gets US FDA Panel Nod For Dialysis Patients

 
• By Sue Sutter

Tenapanor could be an option for dialysis patients who cannot tolerate phosphate binder therapy or who need more help in reaching their serum phosphorous targets, advisory committee members said; Office of New Drugs director Peter Stein is expected to rule on Ardelyx’s appeal of a complete response letter within 30 days.

Ocean tide
Positive adcomm vote may have turned the tide on tenapanor's approval prospects in chronic kidney disease. • Source: Shutterstock

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