FDA Accepts Unicycive’s NDA for Oxylanthanum Carbonate, PDUFA Date June 2025

Unicycive Therapeutics, Inc., a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, oxylanthanum carbonate could significantly reduce the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis.

Publish Date: 11-11-2024 Source: Unicycive Therapeutics, Inc.

Chronic kidney disease (CKD) is characterized by kidney damage lasting over three months, indicated by abnormal albumin excretion or decreased kidney function as measured by glomerular filtration rate (GFR). Diabetes and high blood pressure are its primary causes. In children, CKD typically results from structural anomalies or inherited conditions like polycystic kidney disease. CKD is categorized into five stages based on GFR test results. As the stages progress, kidney function declines. Slowing down kidney damage is crucial at each stage. Screening for CKD involves two standard tests: GFR and urine albumin. Metformin is the preferred treatment for type 2 diabetes with CKD, usually starting with an eGFR above 45 mL/min/1.73 m2 and continuing safely until it drops to 30 mL/min/1.73 m2. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists can reduce CKD progression. SGLT-2 inhibitors may slow CKD progression and reduce heart failure-related hospitalizations, though their effect on mortality is uncertain. CKD can affect multiple body systems, leading to fluid retention, swelling, high blood pressure, pulmonary edema, hyperkalemia, anemia, and heart disease.

Approximately 14% of US adults, roughly 35.5 million people, have CKD, with women slightly more affected than men (15.93% vs. 13.52%).

However, the current Chronic kidney Disease (CKD) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (MB-102, Ferumoxytol, Ravulizumab, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Chronic kidney Disease (CKD) treatment. The key companies in the advanced development stage are MediBeacon, AMAG Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Chronic kidney Disease (CKD) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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