Ardelyx Inc (NASDAQ: ARDX) recently announced that certain health regulatory bodies such as the Centre for Disease Control and the Food and Drugs Authority offered a temporary answer to the company’s second phase of Appeal served on 28th July for its latest product XPHOZAH. One of the regulatory bodies, the Office of New Drugs, stated that the extra information issued by the Cardiovascular and Renal Drug Advisory Committee and other health experts would be crucial in deciding the clinical significance of reducing phosphate in the patients recruited in recent clinical trials.
The company expects a reply to its appeal in thirty days
The Office of New Drugs Department plans to order the sector of Cardiology and Nephrology to provide the drug to the committee together with a reply to the company’s appeal. This reply is to be served before the end of thirty days following the termination of the committee’s gathering. Ardelyx is seeking permission for its drug XPHOZAH for use in adults experiencing fatal kidney illnesses or undergoing dialysis.
During the announcement, Mike Raab, the founder and CEO of Ardelyx, stated that the company is thrilled with the temporary answer that the regulatory bodies issued. Raab further stated that Ardelyx anticipated the date of the meeting and was expecting a notice regarding the date and venue of the meeting so that it could enlighten the committee on the advancement of XPHOZAH.
The treatment reduces phosphate absorption
The proposed drug is an evolutional phosphate absorption inhibitor that distinctly behaves as a blocking method that hinders the production of Sodium Hydrogen -3. The mechanism, in turn, reduces the absorption of phosphate and requires a single 30mg pill dose. The drug has non-severe side effects, such as diarrhoea.
Ardelyx Inc aims to identify, create and commercialise specific drugs that obtain an excellent solution to many malignant illnesses, including heart and kidney illnesses, among others.
Some of the authorised drugs created by Ardelyx include IBSRELA, which is only accessed in the U.S. The drug, XPHOZAH, underwent three mandatory clinical trials; thus, the company is further creating the RDX013 that assists patients with hyperkalaemia.
