Ardelyx wins lengthy battle for FDA approval of kidney-disease remedy 

Ardelyx Inc.
on Tuesday received its lengthy struggle for U.S. regulatory approval of a remedy designed to assist sufferers with continual kidney illness.

The biopharma firm mentioned late Tuesday that the U.S. Food and Drug Administration authorised tenapanor, marketed underneath the model identify Xphozah, for management of serum phosphorus in sufferers with continual kidney illness on dialysis. A excessive degree of phosphorus within the blood is commonly an indication of kidney harm and may result in weak bones, joint ache, cardiovascular issues and different points.    

The approval concludes a unprecedented comeback for Xphozah. Ardelyx’s software for approval of the remedy was beforehand rejected by the FDA in July 2021, when the company mentioned the drug’s impact was “small and of unclear clinical significance.” To protect money, Ardelyx a couple of months later mentioned it could minimize its workforce by 65%, but it surely additionally pursued a number of appeals of the company’s resolution. An FDA advisory committee voted final November that the advantages of Xphozah outweigh its dangers. The company late final yr in the end granted Ardelyx’s attraction, and the corporate resubmitted its Xphozah software to the FDA in April. 

More than 550,000 folks within the U.S. have continual kidney illness and are on upkeep dialysis. The overwhelming majority of them have excessive phosphorus ranges, additionally known as hyperphosphatemia, in response to Ardelyx. 

High phosphorus ranges “must be taken care of in these patients, and the current therapies are mostly insufficient in doing so,” Ardelyx CEO Mike Raab advised MarketWatch. 

Chronic kidney illness sufferers with excessive phosphorus ranges have historically been handled with phosphate binders that may take in phosphorus from meals throughout digestion, however that method can require sufferers to swallow numerous capsules. The Xphozah remedy requires two capsules a day, “each the size of a Tic Tac,” Raab mentioned. 

The FDA authorised Xphozah as add-on remedy in sufferers who can’t tolerate or have an insufficient response to phosphate binders, Ardelyx mentioned in a launch.

Xphozah, which will probably be Ardelyx’s second U.S. product launch, ought to be out there someday in November, Raab mentioned.

Ardelyx will current up to date information on Xphozah for hyperphosphatemia at an American Society of Nephrology assembly in early November, the corporate mentioned in a launch Monday. 

Ardelyx shares jumped in late September after Japanese regulators authorised tenapanor for hyperphosphatemia in adults with continual kidney illness on dialysis. 

Ardelyx shares fell 0.6% on Tuesday and have gained 21% within the yr thus far, whereas the S&P 500
has gained 13.9%. 

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