Kerendia FDA Approval History
Last updated by Judith Stewart, BPharm on July 13, 2021.
FDA Approved: Yes (First approved July 9, 2021)
Brand name: Kerendia
Generic name: finerenone
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Chronic Kidney Disease Associated with Type 2 Diabetes
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) for the treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
- Kerendia is indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
- Kerendia works by blocking overactivation of the mineralocorticoid receptor (MR). Mineralocorticoid receptor overactivation is thought to contribute to fibrosis and inflammation which can contribute to permanent structural kidney damage.
- Kerendia tablets are taken once daily with or without food.
- The Kerendia label contains a Warning and Precaution that Kerendia can cause hyperkalemia. Serum potassium levels should be monitored.
- Common adverse reactions include hyperkalemia (high potassium levels), hypotension (low blood pressure), and hyponatremia (low sodium levels).
Development timeline for Kerendia
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