Lupkynis Approved for Active Lupus Nephritis
The approval was based on data from the pivotal phase 3 AURORA and phase 2 AURA-LV studies.
Kidney Disease
MPR Weekly Dose Podcast Episode 64
This week we have news of the neutralizing response of the Pfizer-BioNTech vaccine to the new COVID-19 variant; A trial investigated ravulizumab in adults with severe COVID is halted; A rapid blood test for concussions gets the all clear; A novel treatment for chronic kidney disease in patients with type 2 diabetes; And the drug manufacturer Fresenius Kabi announces a voluntary recall of one lot of an NSAID treatment.
Sparsentan Granted Orphan Drug Status for IgA Nephropathy
Sparsentan is an investigational small molecule candidate designed to selectively block the receptors of endothelin type A and angiotensin II type I, which are associated with kidney disease progression.
Finerenone Gets Priority Review for Diabetic Kidney Disease
The FDA has accepted for Priority Review the NDA for finerenone for chronic kidney disease in patients with type 2 diabetes.
Dapagliflozin Under Review for Chronic Kidney Disease
The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
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.
Glecaprevir and Pibrentasvir Aid HCV D+/R- Kidney Transplants
Two studies demonstrate safe transplant of kidneys from deceased donors with HCV infection.
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”.
Factors Contributing to Darbepoetin Responsiveness in CKD
In a Japanese study, approximately 1 in 8 CKD patients with anemia failed to respond to darbepoetin alfa therapy.
Tenapanor Under Review for Hyperphosphatemia in CKD
Tenapanor is a first-in-class oral medication that works by blocking the NHE3 transporter in the gastrointestinal tract.
