Padcev Receives Full Approval andNew Indication to Treat Urothelial Cancer
July 9, 2021Darzalex Faspro Receives New Multiple Myeloma Indication
July 12, 2021Kerendia Approved to Treat Chronic Kidney Disease Associated with Type 2 Diabetes
July 9, 2021 – The U.S. FDA has approved Kerendia® (finerenone), manufactured by Bayer, to reduce the risk of sustained eGFR decline (a measure of kidney function), end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction (heart attack), and hospitalization for heart failure in adult patients who have chronic kidney disease (CKD) associated with type 2 diabetes.
Type 2 diabetes can cause CKD, which can lead to kidney failure, also known as end-stage kidney disease. At this stage, a patient is no longer able to survive without dialysis or a kidney transplant. In addition to kidney problems, CKD can contribute to the development of cardiovascular disease, putting patients at risk of heart attack, heart failure, and cardiovascular death.
In a clinical study, reduction in kidney function of at least 40%, progression to kidney failure, and/or kidney death occurred in 600 of the 2,841 patients given a placebo compared to 504 out of 2,833 patients on Kerendia. A non-fatal heart attack, non-fatal stroke, hospitalization for heart failure, and/or cardiovascular death occurred in 420 of the patients receiving placebo versus 367 of the patients taking Kerendia.
Recommended dosing is 10mg or 20mg orally once a day, based on the patient’s eGFR and serum potassium levels. If clinically appropriate, patients started at 10mg once a day can have their dose increased to 20mg once daily after four weeks of treatment.
Kerendia has launched at a wholesale acquisition cost (WAC) of $569.10 per 30 tablets.