December 2021: 5 Notable Drug Approvals
Review the December 2021 notable drug approvals.
Review the December 2021 notable drug approvals.
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.
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.
But dose reduced because of increased incidence of serious adverse events with full-dose methylprednisolone
Cortrophin Gel is a purified adrenocorticotropic hormone.
Purified Cortrophin Gel is a purified adrenocorticotropic hormone.
The FDA noted that the application could not be approved in its present form and had requested an additional clinical study be conducted.
The approval was based on data from the phase 3 FIDELIO-DKD trial.
Soaanz is a loop diuretic with an extended duration of action lasting approximately 6 to 8 hours.
The study evaluated finerenone in addition to standard of care in patients with chronic kidney disease and type 2 diabetes.