Tenapanor, Ardelyx's Kidney Disease Drug Approved by U.S. FDA


eMediNexus    01 January 2023

The U.S. Food and Drug Administration approved Ardelyx Inc.s request to evaluate its experimental kidney disease drug “Tenapanor”.


The company said it now aims to fill the marketing application for the drug, Tenapanor, in the first half of 2023. The health regulator postponed its decision on the appeal earlier this month after holding a meeting of its advisory committee in November.


Last month, the FDA′s advisors voted to approve the medicine as a stand-alone therapy and in combination with other treatments for lowering excessive phosphate levels in dialysis patients′ blood.


Due to the company′s appeal, the U.S. health regulator had to reevaluate its decision to deny the drugs license last year and call for an advisory panel meeting.


Tenapanor is an oral medication that blocks the pathway where phosphate is absorbed from the body. The drug, marketed as Ibsrela, has previously received approval for treating irritable bowel syndrome in the United States and Canada.


Following issues with the drug′s early studies, Ardelyx paid AstraZeneca Plc $25 million to acquire the drug′s rights and develop it independently.


(Source: https://health.economictimes.indiatimes.com/news/pharma/u-s-fda-grants-appeal-for-ardelyxs-kidney-disease-drug/96622978)

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