Bayer's Kerendia gets EU approval to compete with AZ and Eli Lilly's SGLT-2 inhibitors

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Recently, Bayer's new kidney disease drug Kerendia (finerenone, feneridone, 10mg or 20mg) was approved in the European Union, the drug is the first non-steroidal, selective mineralocorticoid receptor antagonist (MRA), Indicated for the treatment of chronic kidney disease (CKD, stages 3 and 4 with proteinuria) associated with type 2 diabetes (T2D) in adult patients

The approval is based on the results of the Phase 3 FIDELIO-DKD trial

In July 2021, Kerendia received its first regulatory approval in the United States based on the aforementioned trial data

Kerendia's mechanism of action differs from existing therapies, in that the drug works by blocking the over-activation of the mineralocorticoid receptor (MR)

In the field of kidney disease, the biggest problem Kerendia will face is that given the 2 SGLT-2 inhibitors on the market - AstraZeneca Forxiga/Farxiga (dapagliflozin, dapagliflozin) and Eli Lilly/Boehringer Ingelheim Jardiance (empagliflozin) , empagliflozin), and what are the commercial prospects of the drug

Bayer's position is that Kerendia is not so much a direct competition with SGLT2 inhibitors as it is a complementary therapy that could be used alongside them to improve existing treatment options

As with other complex diseases such as heart failure, patients may respond more to some classes of drugs than others, and Kerendia may be used in combination with SGLT-2 inhibitors

Since FDA approval, Bayer also reported results from a second Phase 3 clinical study (FIGARO-DKD), which focused on cardiovascular endpoints and also included patients with early-stage kidney disease

Following data submission, Kerendia received a Class A recommendation in the American Diabetes Association's (ADA) new treatment guideline "2022 Standards of Care in Diabetes" issued in December 2021 for the treatment of increased risk of cardiovascular events or CKD progression or inability to use T2D and CKD patients with SGLT2 inhibitors

Kerendia also has the advantage that it does not work as a diabetes treatment like the class of SGLT-2 inhibitors

"The worrying reality is that chronic kidney disease is the leading cause of end-stage renal disease in people with type 2 diabetes, which means that eventually the kidneys no longer support the body's functional needs, and patients need Dialysis or kidney transplantation is required to survive

Meanwhile, Bayer is also evaluating Kerendia in a Phase 3 clinical study for the treatment of heart failure, including heart failure with preserved ejection fraction (HFpEF), a particularly difficult-to-treat type of heart failure

Reference source: EU clears Bayer's chronic kidney disease drug Kerendia