Ardelyx has struck gold on its third attempt with Xphozah (tenapanor), the chronic kidney disease medication. Following two prior rejections, the FDA has granted its long-awaited approval. Xphozah, an innovative phosphate absorption inhibitor, is now officially sanctioned for the management of serum phosphate levels in adult chronic kidney disease patients undergoing dialysis, particularly those who cannot tolerate conventional phosphate binders or exhibit insufficient responses to such treatments.
The company estimates that the condition, known as hyperphosphatemia, impacts the majority of the 550K U.S. patients undergoing maintenance dialysis for chronic kidney d...