FDA Approves Oxlumo for Primary Hyperoxaluria Type 1
Lumasiran is an investigational ribonucleic acid interference therapeutic that inhibits hepatic production of oxalate by targeting hydroxyacid oxidase 1.
Urologic Disorders
Disproportionality Signal Found for Suicidality in Finasteride Users
Younger patients and those with alopecia have significant disproportionality signals for increased suicidality
Finerenone NDA Submitted for Diabetic Kidney Disease
The NDA for finerenone is supported by data from the double-blind, placebo-controlled phase 3 FIDELIO-DKD trial.
OAB Drug May Improve Outcomes in Botulinum Toxin Recipients
Pharmacologic therapy may improve symptoms in patients with refractory overactive bladder who receive intravesical onabotulinum toxin-A injections.
Novel Medication Relieves Pruritus in Hemodialysis Cases
Difelikefalin, an investigational intravenous drug, improved moderate to severe itching compared with placebo in patients on hemodialysis, according to phase 3 trial results.
Apabetalone Prevents CV Events in High-Risk Diabetic CKD
In the BETonMACE trial, CKD patients with type 2 diabetes who recently experienced acute coronary syndrome who received apabetalone had a significant 50% reduction in the risk for major cardiovascular events compared with placebo.
Finerenone Slows CKD Progression in Diabetic Kidney Disease
Finerenone vs placebo added to standard therapy was associated with a significant 18% reduction in the risk for major adverse kidney events in patients with both chronic kidney disease and type 2 diabetes mellitus.
Glecaprevir and Pibrentasvir Aid HCV D+/R- Kidney Transplants
Two studies demonstrate safe transplant of kidneys from deceased donors with HCV infection.
FDA Approves New Formulation of Ultomiris for PNH and aHUS
The FDA has approved a new 100mg/mL formulation of Ultomiris® (ravulizumab-cwvz; Alexion Pharmaceuticals) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and pediatric patients.
Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
