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2021-07-12| Trials & Approvals

FDA Okays Bayer’s Kidney Disease Drug, Kicking Off Market Rivalry Against Established SGLT-2 Inhibitors

by Rajaneesh K. Gopinath
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Chronic Kidney Disease (CKD) is an illness that affects close to 700 million people globally. It is characterized by the progressive loss of kidney function leading to high blood pressure, anemia, and nerve damage. It also puts patients at an increased risk of cardiovascular events like heart failure and subsequently premature death.

Diabetes is one of the common causes of CKD. According to a 2019 estimate, the International Diabetes Federation says that around 463 million people worldwide suffer from diabetes, with 40% at risk for developing CKD.

In 2019, J&J’s SGLT-2 inhibitor Invokana (canagliflozin) was FDA approved for kidney disease associated with type 2 diabetes (T2D). More recently, in April 2021, another SGLT-2 inhibitor, AstraZeneca’s Farxiga, gained approval to treat CKD. Last Friday, the FDA approved yet another CKD drug into the clinic.

 

New Drug Approval

On July 9th, the US drug regulator greenlighted 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 is the first and only nonsteroidal mineralocorticoid receptor antagonist proven to significantly slow chronic kidney disease progression and reduce cardiovascular risk in people with chronic kidney disease associated with type 2 diabetes,” said Amit Sharma, Vice President of Cardiovascular and Renal, Bayer U.S. Medical Affairs, expressing excitement to bring Kerendia to the clinic.

 

Encouraging Study Results

The FDA approval is an outcome of a successful Phase 3 trial, the results of which were published in the New England Journal of Medicine last year. 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).

Results demonstrated that in over 40% of the patients, the drug reduced the incidence of eGFR decline, further reducing complications of kidney failure and renal death. The trial also saw Kerendia reducing cardiovascular-related complications.

“The patient population included in the trial that supported the approval of Kerendia were at risk of chronic kidney disease progression despite receiving standard of care treatment to control blood pressure and blood glucose,” said lead study investigator George Bakris from the University of Chicago. “In people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection.”

With this approval, Bayer is entering a tough market led by AstraZeneca’s blockbuster drug, Farxiga. The multi-faceted SGLT-2 inhibitor raked in $1.964 billion in sales last year, even before its approval for the CKD indication. Meanwhile, J&J’s Invokana brought $795 million in the same period.

Although the competition is fierce, analysts at Evaluate have predicted revenue of $533 million for Kerendia by 2026. The rivalry would further intensify if and when Lilly and Boehringer Ingelheim’s Jardiance, currently under the FDA’s fast-track review, eventually bags approval for CKD.

Related Article: Eli Lilly and Boehringer Ingelheim’s Jardiance Shows Encouraging Phase 3 HFpEF Data

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