Ardelyx’s perseverance pays off as the FDA grants approval for its groundbreaking medication, Xphozah (tenapanor), marking the third attempt as a resounding success.
Xphozah, a pioneering phosphate absorption inhibitor, has received the green light for the management of serum phosphate levels in adult chronic kidney disease patients on dialysis who cannot tolerate or have an insufficient response to conventional phosphate binders.
This milestone is especially significant, given that hyperphosphatemia, also known as high phosphate levels, affects a substantial portion of the 550,000 chronic kidney disease patients in the United States who rely on maintenance dialysis, as indicated by Ardelyx.
The journey to this pivotal achievement has been riddled with challenges, commencing with a disheartening FDA complete response letter in 2021. During this period, the FDA expressed reservations about the medication’s treatment effectiveness, deeming it “small and of unclear clinical significance.”
This turn of events surprised both Ardelyx and industry analysts. Piper Sandler analysts, at the time, found themselves puzzled by the FDA’s seemingly inconsistent feedback regarding the application.
Rather than embarking on another clinical trial, Ardelyx adopted an unconventional approach. The company, in a bold move, laid off 65% of its workforce and initiated a Formal Dispute Resolution Request with the FDA’s Office of Cardiology, Hematology, Endocrinology, and Nephrology. Unfortunately, this request was met with a rejection, compelling Ardelyx to escalate the matter to the FDA’s Office of New Drugs. The company’s last-ditch effort proved successful, leading to an advisory committee meeting for a comprehensive review of Xphozah’s clinical data. Following an exhaustive eight-hour discussion, the FDA’s Cardiovascular and Renal Drug Advisory Committee voted 9-4 in favor of the medication.
This victory holds immense significance for Ardelyx, not only as a validation of their persistence but also for their financial prospects. When Ardelyx faced its initial setback, the biotech company boasted a substantial cash reserve of $172 million. However, this amount dwindled significantly as the regulatory journey unfolded, reaching a modest $33.7 million in the first half of 2023. The company now gears up for the anticipated release of Xphozah in November.
It’s worth noting that Ardelyx’s portfolio also includes Ibsrela, a medication for irritable bowel syndrome, which shares the same active ingredient, tenapanor, as Xphozah.
