December 2021: 5 Notable Drug Approvals
Review the December 2021 notable drug approvals.
Diagnosis & Disease Information
Tarpeyo Approved to Reduce Proteinuria in Primary IgA Nephropathy
The approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tarpeyo in 299 adults with primary IgAN.
Potassium Binder Fast Tracked for Reducing CV Outcomes in Chronic Hemodialysis
The effect of sodium zirconium cyclosilicate is being investigated on arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia in the ongoing phase 3 DIALIZE-Outcomes study.
ASN: Steroids Best Placebo in High-Risk IgA Nephropathy
But dose reduced because of increased incidence of serious adverse events with full-dose methylprednisolone
FDA Approves Cortrophin Gel for Certain Chronic Autoimmune Disorders
Cortrophin Gel is a purified adrenocorticotropic hormone.
FDA to Review sNDA for Purified Cortrophin Gel for Multiple Indications
Purified Cortrophin Gel is a purified adrenocorticotropic hormone.
FDA Denies Approval of Roxadustat for Anemia in CKD
The FDA noted that the application could not be approved in its present form and had requested an additional clinical study be conducted.
Kerendia Approved to Reduce CKD Progression, CV Risk in Patients With Diabetic Kidney Disease
The approval was based on data from the phase 3 FIDELIO-DKD trial.
Soaanz Approved for Edema With Heart Failure, Renal Disease
Soaanz is a loop diuretic with an extended duration of action lasting approximately 6 to 8 hours.
Finerenone Improves Cardiovascular Outcomes in Patients With Diabetic Kidney Disease
The study evaluated finerenone in addition to standard of care in patients with chronic kidney disease and type 2 diabetes.
