Ardelyx Inc. has emerged triumphant in its arduous battle for U.S. regulatory approval of a transformative treatment aimed at aiding patients suffering from chronic kidney disease.

The biopharmaceutical company announced on Tuesday that the U.S. Food and Drug Administration (FDA) has approved its innovative drug, tenapanor, for the control of serum phosphorus in dialysis patients with chronic kidney disease. Elevated phosphorus levels in the bloodstream often indicate kidney damage and can precipitate debilitating symptoms such as weakened bones, joint pain, cardiovascular complications, and other related issues.

This approval marks a remarkable turnaround for tenapanor, which initially faced an FDA rejection in July 2021 due to the perceived small effect size and uncertain clinical significance of the drug. In an effort to conserve resources, Ardelyx subsequently implemented significant workforce reductions of up to 65%. Nevertheless, the company persisted in pursuing multiple appeals of the FDA's decision. In November of the same year, an FDA advisory committee voted in favor of the drug, determining that its benefits outweighed the associated risks. Finally, in April, Ardelyx resubmitted its tenapanor application to the FDA, ultimately leading to the recent approval.

With over 550,000 individuals suffering from chronic kidney disease and undergoing maintenance dialysis in the United States, a large majority of them experience high phosphorus levels – a condition commonly referred to as hyperphosphatemia, as affirmed by Ardelyx.

High Phosphorus Levels in Chronic Kidney Disease Patients Require Better Treatment Options

The standard therapies currently available for chronic kidney disease patients with high phosphorus levels are insufficient, according to Ardelyx CEO Mike Raab. These patients have traditionally been prescribed phosphate binders, which help absorb phosphorus from food during digestion. However, this approach often involves consuming a large number of pills. To address this issue, Ardelyx has developed Xphozah, a new treatment that only requires patients to take two pills a day, each the size of a Tic Tac.

The U.S. Food and Drug Administration (FDA) has approved Xphozah as an add-on therapy for patients who either cannot tolerate or do not respond adequately to phosphate binders. Ardelyx expects Xphozah to be available in November this year, marking the company's second product launch in the United States.

Ardelyx will also be presenting updated data on Xphozah for hyperphosphatemia at an upcoming American Society of Nephrology meeting in early November. This will provide further insights into the drug's efficacy in treating high phosphorus levels.

In recent news, Ardelyx saw a significant increase in its stock value after tenapanor, another hyperphosphatemia treatment developed by the company, received approval from Japanese regulators for use in adults with chronic kidney disease on dialysis.

Although Ardelyx shares experienced a slight decrease of 0.6% on Tuesday, they have still gained 21% this year, outperforming the S&P 500 SPX, which has seen a growth of 13.9%.

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