GERMANY – Bayer has claimed European Union approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company attempts to position the drug alongside rival therapies from AstraZeneca and Johnson & Johnson.

The approval is based on the phase 3 FIDELIO-DKD trial, which found that when combined with the highest tolerated dose of standard therapy, Kerendia (finerenone) reduced the risk of kidney disease progression or renal death by 18%.

The drug also reduced cardiovascular outcomes by 14%, including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure.

Kerendia, an oral, non-steroidal mineralocorticoid receptor (MR) antagonist, received its first regulatory approval in the United States last summer, capping off several years of clinical development and a sizable investment in three large-scale clinical trials.

The European approval keeps Bayer on track for the new drug’s global rollout, but the big question is how the drug will fare commercially, given competition from AstraZeneca’s Forxiga/Farxiga (dapagliflozin) and Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), two Sodium-glucose transport protein 2 (SGLT2) inhibitors that showed stronger effects on CKD in phase 3 trials.

According to Bayer, Kerendia is not a direct competitor to the SGLT2 drugs, but rather a complementary therapy that could be used alongside them to improve treatment options.

Patients may respond better to some classes of drugs than others, as in other complex diseases such as heart failure, and Kerendia may be used in combination with SGLT2 inhibitors.

An estimated 160 million people worldwide suffer from diabetes and CKD.

Bayer has also reported the results of a second phase 3 trial – FIGARO-DKD – that focused primarily on cardiovascular endpoints and included patients with earlier-stage kidney disease since the FDA approval.

Kerendia reduced cardiovascular events by 13% compared to placebo in the study, with a 14% reduction when the results from both the FIDELIO-DKD and FIGARO-DKD trials were combined. Renal complications were reduced by 17%.

Following the presentation of that data, Kerendia claimed a grade A recommendation in the American Diabetes Association’s (ADA) new treatment guidelines for the treatment of patients with CKD and type 2 diabetes who are at increased risk for cardiovascular events or CKD progression or are unable to use an SGLT2 therapy.

It also has the advantage of not acting as a diabetes medication like the SGLT2s, so patients on insulin do not need to adjust their dose if Kerendia is added to their treatment.

Meanwhile, Bayer is considering taking on SGLT2 inhibitors as well as other drugs such as Novartis’ Entresto (sacubitril/valsartan) in heart failure, including heart failure with preserved ejection fractions (HFpEF), a particularly difficult-to-treat form.

Kerendia, according to the company, has the potential to reach peak annual sales of around €1 billion (US$1.1 billion).

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