The FDA is reviewing Unicycive Therapeutics' oxylanthanum carbonate (OLC) for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, with a decision expected by June 28. This drug aims to address the challenges of existing phosphate binder therapies, potentially improving patient adherence and outcomes.
Addressing Unmet Needs in Hyperphosphatemia Treatment
Hyperphosphatemia, a common complication of CKD, particularly affects dialysis patients. Elevated phosphate levels can lead to bone and muscle problems, and increase the risk of cardiovascular events like heart attacks and strokes. Despite the availability of six FDA-approved phosphate binders, approximately 75% of patients fail to achieve target serum phosphorus levels, contributing to increased hospitalization and mortality.
Unicycive's OLC is being developed as a more patient-friendly alternative to existing treatments like Takeda's Fosrenol (lanthanum carbonate). Current options often involve large chewable tablets or require patients to take numerous pills daily – up to 12 in some cases. Unicycive's CEO, Shalabh Gupta, suggests that OLC's smaller pill size and ease of swallowing could offer "meaningful patient adherence benefits." The company is seeking approval for a regimen of one tablet (similar in size to a regular-strength aspirin) taken three times per day.
Clinical Trial Data and Regulatory Pathway
In a pivotal trial, 69% of evaluable patients achieved their target serum phosphate level at a dose of 500mg of OLC taken three times daily. Unicycive filed for approval using the 505(b)(2) regulatory pathway, a streamlined process that allows the company to leverage existing data from the originator drug. This approach allowed Unicycive to support its marketing application with three clinical trials: a phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in CKD patients on dialysis.
Market Opportunity
The global market for hyperphosphatemia therapies is estimated at around $2.5 billion, with the U.S. accounting for $1.1 billion. In the U.S., over half a million patients are on dialysis, and approximately 400,000 are using phosphate binders. A 2022 survey commissioned by Unicycive indicated that kidney disease specialists view lower pill burden and improved patient compliance as the greatest unmet needs in hyperphosphatemia treatment with phosphate binders.
"We are thrilled with the FDA acceptance of our first NDA, a significant milestone towards our efforts to bring this important treatment option to patients with kidney disease if approved," said Gupta.
