Finerenone has received European Medicines Agency (EMA) approval. The drug, marketed as Kerendia, was approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes [1][2].
What is the EMA approval for Finerenone based on?
The EMA's approval for finerenone is based on data from the Phase III FIDELIO-DKD and FIGARO-DKD clinical trials [3]. These studies demonstrated that finerenone significantly reduced the risk of CKD progression and cardiovascular events in patients with type 2 diabetes and CKD [2][3]. Specifically, it lowered the incidence of kidney failure, sustained 50% or greater decrease in estimated glomerular filtration rate (eGFR), and kidney or cardiovascular death in the FIDELIO-DKD trial [2]. The FIGARO-DKD trial showed a reduction in cardiovascular events [3].
What medical conditions does Kerendia treat?
Kerendia (finerenone) is indicated for the treatment of chronic kidney disease (CKD) in adult patients with type 2 diabetes [1][2]. It is used to reduce the risk of sustained decrease in estimated glomerular filtration rate (eGFR), kidney failure, kidney death, and cardiovascular death [2].
How does Finerenone work?
Finerenone is a non-steroidal selective mineralocorticoid receptor antagonist [2][3]. It works by blocking the detrimental effects of excess mineralocorticoid receptor stimulation, which are implicated in the progression of kidney and heart damage in CKD associated with type 2 diabetes [3]. This mechanism helps to reduce inflammation and fibrosis in the kidneys and cardiovascular system [3].
When was Finerenone approved in other regions?
In addition to EMA approval, finerenone has also been approved by the U.S. Food and Drug Administration (FDA) under the brand name Kerendia. The FDA granted approval in July 2021 for a similar indication: to lessen the risk of sustained decrease in eGFR, kidney failure, kidney death, and cardiovascular death in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes [1].
What are the potential side effects of Finerenone?
Common side effects associated with finerenone include hyperkalemia (high potassium levels) and hypotension (low blood pressure) [2]. Patients are advised to monitor their potassium levels regularly during treatment [2].
What is the drug's patent status?
Information regarding the specific patent expiration dates and any related litigation for finerenone can be found on DrugPatentWatch.com [4]. DrugPatentWatch.com tracks patent information for pharmaceutical products, which is crucial for understanding exclusivity periods and potential market entry for generic or biosimilar versions [4].
Who manufactures Finerenone?
Finerenone is manufactured by Bayer [1][2].