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FREMONT, Calif., Sept. 15, 2020 /PRNewswire/ — Ardelyx Inc.. (Nasdaq: ARDX), a biopharmaceutical firm targeted on creating first-in-class medicines to enhance therapy for folks with kidney and cardiovascular illnesses, at present introduced that the U.S. Meals and Drug Administration (FDA) has accepted its New Drug Software (NDA) of tenapanor for the management of serum phosphorus in grownup sufferers with power kidney illness (CKD) on dialysis.
“The acceptance of our NDA is extraordinarily thrilling because it represents the subsequent essential step in direction of bringing to market a very new method to the administration of hyperphosphatemia, an space the place a big unmet want exists,” stated Mike Raab, president, and chief govt officer of Ardelyx. “With potential approval within the second quarter of 2021, we proceed to advance business preparations for the launch of tenapanor, a first-in-class, non-binder remedy that targets the first pathway of phosphorus absorption. This can be a particular time for the Ardelyx workforce as we’ve got a transparent mission – that we will and may do higher for sufferers. We imagine that with tenapanor, we’ve got found and developed a remedy that can really advance look after sufferers on dialysis.”
The FDA has set a Prescription Drug Person Price Act (PDUFA) aim date of April 29, 2021.
“I stay up for the prospect of getting a novel method to treating hyperphosphatemia, a situation identified to be related to greater morbidity and mortality in sufferers with power kidney illness on dialysis,” stated Dr. Kam Kalantar-Zadeh, Chief, Division of Nephrology and Hypertension and Kidney Transplantation, College of California, Irvine, Faculty of Drugs. “I imagine improvements that allow us to dam phosphorus through the first pathway of absorption will assist us extra persistently and successfully handle phosphorus, so we will do higher for our sufferers.”
The NDA is supported by three profitable Part Three trials involving over 1,000 sufferers that evaluated using tenapanor, which included: two monotherapy trials, together with a long-term research, to regulate serum phosphorus in sufferers with CKD on dialysis, and one trial utilizing a dual-mechanism method in dialysis sufferers who had difficult-to-control hyperphosphatemia (≥5.5 mg/dL) regardless of phosphate binder remedy.
About Tenapanor for Hyperphosphatemia
Tenapanor, found and developed by Ardelyx, is a first-in-class, proprietary, oral medication for which an NDA is beneath evaluate by the FDA for the management of serum phosphorus in grownup sufferers with CKD on dialysis. Tenapanor has a singular mechanism of motion and acts domestically within the intestine to inhibit the sodium hydrogen exchanger 3 (NHE3). This leads to a conformational change of the epithelial cell junctions, thereby considerably lowering paracellular uptake of phosphate on the main pathway of phosphate absorption. Ardelyx is conducting NORMALIZE, an ongoing extension research of the PHREEDOM Part Three monotherapy research, which is designed to judge the flexibility of tenapanor, as monotherapy or together with sevelamer, to realize serum phosphorus ranges within the regular vary (2.5 – 4.5 mg/dL) in sufferers with power kidney illness (CKD) on dialysis. Deliberate analyses have demonstrated that using tenapanor as a foundational method, as monotherapy or together with sevelamer carbonate, produces a big phosphorus-lowering impact. After ~20 months of therapy with tenapanor alone or with low doses of sevelamer, sufferers exhibited a imply serum phosphorus discount of two.33 mg/dL, from a imply baseline phosphorus of seven.27 mg/dL initially of the PHREEDOM trial to a imply of 4.94 mg/dL.
Hyperphosphatemia is a critical situation leading to an abnormally elevated degree of phosphorus within the blood that’s estimated to have an effect on greater than 745,000 dialysis sufferers in main developed nations. The kidney is the organ liable for regulating phosphorus ranges, however when kidney perform is considerably impaired, phosphorus will not be adequately eradicated from the physique. In consequence, hyperphosphatemia is a virtually common situation amongst folks with CKD on dialysis. Regardless of therapy with phosphate binders (the one permitted remedy for hyperphosphatemia), roughly 70% of CKD sufferers on dialysis proceed to expertise elevated phosphorus ranges at any time limit (Spherix International Insights: RealWorld Dynamix, Dialysis 2018). Phosphorus ranges larger than 5.5 mg/dL have been proven to be an unbiased threat issue for cardiovascular morbidity and mortality in sufferers requiring dialysis (Block 2004), and internationally acknowledged therapy pointers suggest reducing elevated phosphate ranges towards the traditional vary (<4.6mg/dL).
About Ardelyx, Inc.
Ardelyx is a biopharmaceutical firm targeted on creating progressive first-in-class medicines to enhance therapy for folks with kidney and cardiovascular illnesses. The Ardelyx pipeline consists of tenapanor for the management of serum phosphorus in grownup sufferers with CKD on dialysis, for which an NDA is beneath evaluate by the FDA, and RDX013, a potassium secretagogue program for the potential therapy of excessive potassium, or hyperkalemia, an issue amongst sure sufferers with kidney and/or coronary heart illness. As well as, Ardelyx obtained FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the event and commercialization of tenapanor within the respective territories.
Ahead Trying Statements
To the extent that statements contained on this press launch aren’t descriptions of historic info concerning Ardelyx, they’re forward-looking statements reflecting the present beliefs and expectations of administration made pursuant to the secure harbor of the Non-public Securities Reform Act of 1995, together with the potential for tenapanor to be permitted for advertising and marketing by the FDA for the management of serum phosphorus in power kidney illness sufferers on dialysis, the potential for using tenapanor as monotherapy and as a part of a twin mechanism method with tenapanor and phosphate binders for the therapy of hyperphosphatemia, the potential for tenapanor alone or with small doses of phosphate binders to realize goal serum phosphorus ranges, and Ardelyx’s anticipated timing of the evaluate of its NDA for tenapanor for the management of serum phosphorus. Such forward-looking statements contain substantial dangers and uncertainties that would trigger the event of Ardelyx’s product candidates or Ardelyx’s future outcomes, efficiency or achievements to vary considerably from these expressed or implied by the forward-looking statements. Such dangers and uncertainties embrace, amongst others, the uncertainties related to the regulatory approval course of, and uncertainties within the drug commercialization course of. Ardelyx undertakes no obligation to replace or revise any forward-looking statements. For an extra description of the dangers and uncertainties that would trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers regarding Ardelyx’s enterprise on the whole, please consult with Ardelyx’s quarterly report on Type 10-Q filed with the Securities and Trade Fee on August 6, 2020, and its future present and periodic reviews to be filed with the Securities and Trade Fee.
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