Unicycive Submits NDA to FDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis
核心洞察
Unicycive Therapeutics has submitted an NDA to the FDA for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia (搜索) in chronic kidney disease (搜索) (CKD) patients on dialysis.
The NDA is supported by data from three clinical studies, multiple preclinical studies, and CMC specifications, seeking approval via the 505(b)(2) regulatory pathway.
OLC, a next-generation lanthanum-based phosphate binder, aims to reduce pill burden and improve patient compliance compared to existing treatments.
Unicycive Therapeutics, Inc. has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia (搜索) in patients with chronic kidney disease (搜索) (CKD) on dialysis. The company is pursuing approval via the 505(b)(2) regulatory pathway.
The NDA submission is based on data from three clinical studies, including a Phase 1 study in healthy volunteers, a bioequivalence study, and a tolerability study in CKD patients on dialysis. Multiple preclinical studies and CMC data were also included in the submission package.
Potential Benefits of Oxylanthanum Carbonate
Oxylanthanum carbonate is described as a next-generation lanthanum-based phosphate binding agent that utilizes proprietary nanoparticle technology. Unicycive aims to address the unmet need for lower pill burden and improved patient compliance in hyperphosphatemia (搜索) management. According to a 2022 survey, nephrologists identified these factors as the greatest challenge with current phosphate binders.
Shalabh Gupta, MD, Chief Executive Officer of Unicycive, stated, "With this NDA submission, we are excited to be one step closer to our goal of bringing OLC to patients with chronic kidney disease (搜索) who are living with hyperphosphatemia (搜索). We believe our data support a differentiated and best-in-class therapy that will maintain phosphate control while reducing the onerous pill burden patients currently have to manage."
Hyperphosphatemia in Chronic Kidney Disease
Hyperphosphatemia (搜索) is a common and serious condition affecting nearly all patients with End Stage Renal Disease (ESRD). Untreated hyperphosphatemia can lead to secondary hyperparathyroidism (搜索) (SHPT), renal osteodystrophy (搜索), and cardiovascular disease. It is also independently associated with increased mortality in dialysis patients. Current treatment strategies involve dietary phosphorus restriction and the use of oral phosphate binders taken with meals to facilitate fecal elimination of dietary phosphate.
Market Opportunity
The global market for hyperphosphatemia (搜索) treatment is expected to exceed $2.5 billion, with the United States accounting for over $1 billion. Despite the availability of several FDA-approved medications, 75% of U.S. dialysis patients fail to achieve target phosphorus levels, highlighting the need for improved therapies.
Unicycive also reported that the FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees which is a significant savings of approximately $4 million.