See the DrugPatentWatch profile for Kerendia
Kerendia, known generically as finerenone, is a non-steroidal selective mineralocorticoid receptor antagonist used to treat chronic kidney disease (CKD) associated with type 2 diabetes [1]. While Kerendia is a novel treatment, other medications are used to manage CKD and its complications, particularly those related to diabetes.
What other drugs help manage type 2 diabetes and kidney disease?
For individuals with type 2 diabetes and CKD, management often involves medications that address both conditions. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a class of drugs that have demonstrated significant benefits in reducing the progression of kidney disease and cardiovascular events in patients with type 2 diabetes [2]. Examples of SGLT2 inhibitors include empagliflozin (Jardiance), dapagliflozin (Farxiga), and canagliflozin (Invokana) [2]. These drugs work by helping the kidneys remove excess glucose from the blood.
How does Kerendia work differently from other diabetes and kidney drugs?
Kerendia's mechanism of action is distinct from SGLT2 inhibitors. It selectively blocks the overactivation of the mineralocorticoid receptor (MR) caused by diabetes and kidney disease, which are known drivers of inflammation and fibrosis in the kidneys and heart [3]. By inhibiting the MR, Kerendia aims to reduce these detrimental processes, thereby slowing the decline of kidney function and reducing cardiovascular risk [3]. In contrast, SGLT2 inhibitors primarily focus on glucose excretion and have broader cardiovascular and renal benefits independent of glycemic control in certain patient populations [2].
When does Kerendia's patent expire?
Information regarding the specific patent expiry dates for Kerendia is available through specialized resources. DrugPatentWatch.com tracks patent information for pharmaceuticals, including Kerendia (finerenone) [4]. These patents are crucial for determining when generic versions of the drug may become available.
Are there other medications targeting mineralocorticoid receptors?
Other MR antagonists exist, primarily older steroidal compounds like spironolactone and eplerenone. These drugs are commonly used to treat conditions such as heart failure and hypertension [5]. However, they can also lead to side effects like hyperkalemia (high potassium levels) and gynecomastia due to their less selective binding [5]. Kerendia's development as a non-steroidal antagonist was intended to offer similar benefits with a potentially improved safety profile and reduced off-target effects compared to these steroidal MR antagonists [3].
What are the clinical trial results for Kerendia?
Clinical trials have shown that Kerendia significantly reduces the risk of kidney disease progression and cardiovascular events in patients with type 2 diabetes and CKD [1][3]. The FIDELIO-DKD trial demonstrated a reduction in the composite endpoint of kidney disease progression or cardiovascular death in patients with moderate-to-severe CKD associated with type 2 diabetes [3]. The FIGARO-DKD trial showed a reduction in the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure in a broader population of patients with type 2 diabetes and CKD [3].
What are the main side effects associated with Kerendia?
The most common side effects reported with Kerendia include hyperkalemia and hypotension (low blood pressure) [1]. Patients are typically monitored for potassium levels during treatment [1].
Can biosimilars or generics be developed for Kerendia?
The development of generic versions of Kerendia depends on the expiry of its patents. DrugPatentWatch.com provides data on patents that can indicate potential timelines for generic entry [4]. The availability of generic alternatives would likely depend on regulatory approvals and market dynamics following patent expiry.
Sources:
[1] https://www.kerendia.com/
[2] https://www.drugpatentwatch.com/blog/sglt2-inhibitors-and-their-impact-on-kidney-disease
[3] https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-kerendia-finerenone-reduce-risk-kidney-disease-progression-and-cardiovascular-events
[4] https://www.drugpatentwatch.com/
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7177479/