EU Greenlight for Bayer’s Kidney Disease Drug, Kicking off Market Rivalry Against Established SGLT-2 Inhibitors 

Bayer is marking its return to the European Union market with its drug finerenone to treat chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes (T2D) in adults. Yet, questions still swirl over how well the company will face off against established therapies from AstraZeneca, Eli Lilly/Boehringer and Johnson & Johnson.

Chronic Kidney Disease (CKD) is an illness that affects more than 160 million people with T2D worldwide. It is characterized by the progressive loss of kidney function leading to high blood pressure, anemia, and nerve damage.

CKD in type 2 diabetes is the leading cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. Patients with CKD and type 2-diabetes are three times more likely to die from a cardiovascular-related cause than those with type-2 diabetes alone. 

In 2020 J&J’s sodium-glucose cotransporter 2 (SGLT-2) inhibitor Invokana (canagliflozin) was approved in the European Union for kidney disease associated with type-2 diabetes (T2D). Later next year, AstraZeneca’s SGLT-2 inhibitor, Forxiga (dapagliflozin) also received EU nod for the treatment of CKD in adults with and without type-2 diabetes. Last Monday, the EU approved yet another CKD drug into the clinic.

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New Drug Approval

On Feb 21st, the European Commission granted marketing authorization in the European Union for Bayer’s Kerendia (finerenone) to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, kidney failure, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in patients suffering from CKD associated with T2D.

Kerendia® (10 mg or 20 mg), is an oral, non-steroidal, selective mineralocorticoid receptor antagonist. 

It is the first and only non-steroidal, selective mineralocorticoid receptor antagonist proven to protect patients from further kidney damage and reduce cardiovascular risk by slowing down progression of CKD (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Unlike other CKD in T2D treatment modalities, Kerendia acts by blocking mineralocorticoid receptor hyperactivation, which presumably contributes to CKD progression and cardiovascular damage.

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EU Nod for Kerendia

The EU authorization is an outcome of the pivotal Phase III FIDELIO-DKD clinical trial, the results of which were presented at the American Society of Nephrology’s Kidney Week 2020 and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020. 

The FIDELIO-DKD trial enrolled 5,674 patients suffering from CKD associated with T2D, who were randomized to either receive Kerendia (n=2833) or placebo (n=2841).

Strikingly, in July 2021 the U.S. Food and Drug Administration (FDA) okays Kerendia based on the encouraging results of the FIDELIO-DKD Phase III study.

Additionally, in December 2021, Kerendia received a Grade A recommendation in the new treatment guidelines of the American Diabetes Association (ADA), “Standards of Medical Care in Diabetes 2022” for the treatment of patients with CKD associated with T2D who are at increased risk for cardiovascular events or CKD progression or are unable to use a SGLT-2 inhibitor.

Thus, based on the promising results of Kerendia protecting patients from complications of kidney failure, renal death and cardiovascular damage, this multi-faceted mineralocorticoid receptor antagonist vindicates hope for vulnerable CKD patients associated with T2D.

With this approval, Bayer is entering a fierce market in the EU led by AstraZeneca’s blockbuster drug, Forxiga and Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin), that showed stronger effect in CKD in phase III trial. In the EU, Forxiga’s ranked in $372 million in sales last year.

Although the competition is fierce, Kerendia has an edge over SGLT2s. It does not act 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 paradigm.

Despite the rivalry, the company has predicted annual sales of around €1 billion (US$1.1 billion) for Kerendia.

Author

Isha Kapoor