Novel Oral Anticoagulant Fast Tracked for Patients With ESRD and Atrial Fibrillation
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
The application is supported by data from the phase 3 EMPA-KIDNEY trial, which enrolled more than 6600 adults with CKD at risk of kidney disease progression.
The decision to withdraw the indication was made based on findings from the subsequent confirmatory phase 3 IMvigor130 trial.
According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis.
For patients who tolerated and remained on therapy, the average treatment effect on serum phosphorus was about -0.7mg/dL.
The NDA was supported by data from the ASCEND clinical program, which included dialysis and nondialysis patients.
Furoscix is a pH-neutral formulation of furosemide designed for SC administration via a wearable, single-use, pre-programmed on-body infusor for outpatient self-administration.
Vegzelma is a vascular endothelial growth factor inhibitor.
The approval was based on data from the phase 3 ILLUMINATE-C study that included 21 dialysis-independent and -dependent patients with PH1.
The Company is currently evaluating OCE-205 in a phase 2 trial in adults who have developed hepatorenal syndrome with acute kidney injury.