Unicycive Therapeutics Inc (Nasdaq:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced on Monday that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 28 June 2025. If approved, OLC could offer a more convenient treatment option for CKD patients with hyperphosphatemia, requiring fewer pills per dose and easier administration.
The NDA submission is based on data from clinical and preclinical studies, as well as chemistry, manufacturing and controls data.
Unicycive is preparing for a potential commercial launch of OLC in the second half of 2025.
Edwards Lifesciences wins FDA approval for PASCAL Precision tricuspid repair system
GSK wins US FDA approval for chronic hepatitis B treatment Hibsago
Solventum's combined use of Restrata Matrix and Solventum VAC Therapy receives FDA 510(k) clearance
Viatris' RYZUMVI receives US FDA Approval to treat presbyopia
Omeros receives negative EU opinion on narsoplimab after re-examination
Ionis' TRYNGOLZA recommended for EU approval in severe hypertriglyceridemia
FDA approves Genentech's Enspryng as first at-home subcutaneous treatment for thyroid eye disease
EMA issues positive CHMP opinion for Revolution Medicines' RASONQUE in metastatic pancreatic cancer