When was Kerendia Approved?
Novartis's medication Kerendia (finerenone) received its first approval from the U.S. Food and Drug Administration (FDA) on July 9, 2021 [1]. This approval was for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes [1][2].
What Markets Has Kerendia Launched In?
Following its U.S. approval, Kerendia has seen subsequent launches in other major markets. The European Medicines Agency (EMA) granted approval in February 2022 [3]. Later that year, in October 2022, Health Canada authorized the drug for use in Canada [4].
What Does Kerendia Treat?
Kerendia is a non-steroidal, selective mineralocorticoid receptor antagonist indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, cardiovascular events, kidney failure, kidney disease mortality, and cardiovascular death in adults with chronic kidney disease (CKD) associated with type 2 diabetes [1][2].
How Does Kerendia Work?
Finerenone, the active ingredient in Kerendia, works by blocking the harmful effects of excessive mineralocorticoid receptor (MR) activity, which can contribute to kidney damage and cardiovascular disease in individuals with CKD and type 2 diabetes [5]. Unlike older steroidal MR antagonists, finerenone does not have significant hormonal side effects [5].
What is the Expected Market Impact of Kerendia?
Kerendia is considered a significant advancement in the treatment of CKD associated with type 2 diabetes, addressing a large and underserved patient population [6]. Its approval marked a new therapeutic option for preventing kidney and cardiovascular complications in these patients [2].
Are There Other Similar Treatments for CKD in Type 2 Diabetes?
Prior to Kerendia, management of CKD in patients with type 2 diabetes primarily focused on blood pressure and glycemic control, as well as the use of renin-angiotensin system (RAS) inhibitors [7]. Kerendia offers a novel approach by targeting the underlying inflammation and fibrosis pathways driven by MR overactivation [5].
Where Can I Find More Information on Drug Approvals and Market Launches?
For detailed information on drug approvals, patent expirations, and market launches, resources like DrugPatentWatch.com can provide comprehensive data [8].
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Sources:
[1] U.S. Food and Drug Administration. (2021, July 9). FDA Approves New Drug to Treat Chronic Kidney Disease in Adults with Type 2 Diabetes. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-drug-treat-chronic-kidney-disease-adults-type-2-diabetes
[2] Novartis. (2021, July 9). Novartis Receives FDA Approval for KERENDIA® (finerenone), a First-in-Class medicine to reduce the risk of kidney function decline, kidney failure and cardiovascular events in people with chronic kidney disease associated with type 2 diabetes. https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-kerendia-finerenone-first-class-medicine-reduce-risk-kidney-function-decline-kidney-failure-and-cardiovascular-events-people-chronic-kidney-disease-associated-type-2-diabetes
[3] European Medicines Agency. (2022, February 25). KERENDIA. https://www.ema.europa.eu/en/medicines/human/EPAR/kerendia
[4] Health Canada. (2022, October 11). Health Canada approves KERENDIA (finerenone) for the treatment of chronic kidney disease associated with type 2 diabetes. https://www.newswire.ca/news-releases/health-canada-approves-kerendia-finerenone-for-the-treatment-of-chronic-kidney-disease-associated-with-type-2-diabetes-898083383.html
[5] De Nicola, L., & Varenna, M. (2020). Finerenone: a novel non-steroidal selective mineralocorticoid receptor antagonist for the management of diabetic kidney disease. Therapeutic Advances in Endocrinology and Metabolism, 11, 2042018820960675. https://doi.org/10.1177/2042018820960675
[6] Agarwal, R., & Brunelli, S. M. (2022). Finerenone: A Novel Mineralocorticoid Receptor Antagonist for Diabetic Kidney Disease. Cardiorenal Medicine, 12(1), 1-8. https://www.karger.com/Article/FullText/520375
[7] Wanner, C., & J. Mann, J. (2022). Diabetic Kidney Disease: Targeting Mineralocorticoid Receptor Antagonism. Hypertension, 79(2), 239-248. https://doi.org/10.1161/HYPERTENSIONAHA.121.17359
[8] DrugPatentWatch.com. https://drugpatentwatch.com/