A submission has been made for a new drug application by Japanese Kyowa Kirin Co. Ltd. for the improvement of hyperphosphatemia in patients with chronic kidney disease (CKD).\n\n\n\nThe company has submitted the application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for tenapanor, which helps those with CKD on dialysis. \n\n\n\nArdelyx, Inc. a biopharmaceutical company that discovers, develops and commercializes medicines that meet significant unmet medical needs, made the announcement today (October 31) on behalf of its collaboration partner Kyowa Kirin.\n\n\n\nMilestone payment\n\n\n\nThe submission triggers an aggregate of $35 million to Ardelyx in milestone payments and payments under the recent amendment to the license agreement between Ardelyx and Kyowa Kirin.\n\n\n\n“The NDA submission represents important progress toward making tenapanor available in Japan to treat hyperphosphatemia in patients with CKD on dialysis," said Mike Raab, president and chief executive officer of Ardelyx.\n\n\n\n“The data generated by Kyowa Kirin in Japan further supports our extensive clinical results demonstrating the importance of having tenapanor in the armamentarium of treatment options for nephrologists. \n\n\n\nChronic kidney disease \n\n\n\n"We congratulate our partners on their work, and we would like to express our gratitude to them, the hundreds of patients that participated in their clinical studies in Japan, and the medical staff that supported these patients. Together, we share a common vision for the betterment of patients with kidney disease.”\n\n\n\nThe NDA is supported by data from four phase 3 clinical trials, conducted by Kyowa Kirin in Japan in patients with hyperphosphatemia on maintenance dialysis. Across Kyowa Kirin's clinical program, tenapanor demonstrated statistically significant reductions in serum phosphorus levels, with tenapanor both as monotherapy and when added to phosphate binders for patients whose serum phosphorus levels were poorly controlled on phosphate binders alone.\n\n\n\nThe results of the studies undertaken by Kyowa Kirin suggest that tenapanor may also reduce the medication burden of phosphorus management utilizing marketed phosphate binders for treating hyperphosphatemia. In these studies, the safety and tolerability profile for tenapanor was consistent with prior studies in Japan, with no new safety signals identified.\n\n\n\nNew drug application \n\n\n\nYoshifumi Torii vice president at Kyowa Kirin, said: “We are pleased that we have submitted an NDA for tenapanor for improvement of hyperphosphatemia in chronic kidney disease patients on dialysis.\n\n\n\n“We strongly believe that tenapanor, with its unique mechanism of action, will provide a new treatment option for the improvement of hyperphosphatemia and contribute to the benefit of patients receiving maintenance dialysis.”\n\n\n\nIn the U.S., Ardelyx is pursuing approval of tenapanor for the treatment of hyperphosphatemia in adult patients with CKD on dialysis, with the brand name XPHOZAH, and has an appeal underway in response to the complete response letter it received from the U.S Food and Drink Administration (FDA) for its NDA. As part of the appeal process, the FDA will convene an advisory committee meeting to review XPHOZAH on November 16, 2022.