Bayer Kerendia for type 2 diabetes-related chronic kidney disease (CKD) approved in China
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Bayer Kerendia for type 2 diabetes-related chronic kidney disease (CKD) approved in China
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Bayer Kerendia for type 2 diabetes-related chronic kidney disease (CKD) approved in China
Following approvals in the U.S., Europe and Japan, Bayer ‘s Kerendia for type 2 diabetes-related chronic kidney disease (CKD) was recently approved by the NMPA in China .
The new approval of the drug in China is a key factor in Bayer’s plans to turn Kerendia into a blockbuster drug worth more than 1 billion euros, as China has the largest number of adults with diabetes and a high number of CKD patients.
“CKD associated with type 2 diabetes has become one of the most important health crises in China,” as Bayer said in a statement. The company estimates that there are 140 million people with diabetes in China, with another 73 million undiagnosed, and says China also has the highest burden of diabetes-related CKD in the world.
Kerendia is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown in the phase III FIDELIO-DKD clinical trial to reduce renal disease progression or renal disease when added to standard therapy at the highest tolerated dose The risk of death was reduced by 18%.
The drug also reduced cardiovascular outcomes — including death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure — by 14 percent.
Kerendia differs from other emerging diabetes-related CKD drugs — SGLT2 inhibitors — notably AstraZeneca’s Forxiga/Farxiga (dapagliflozin) and Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin) mode of action.
Bayer’s position is that Kerendia is less of a direct competitor to SGLT2 and more of a complementary therapy that could be used alongside SGLT2 inhibitors to improve available treatment options.
Even more advantageously, unlike SGLT2 inhibitors that work as diabetes drugs, there is no need to adjust the patient’s insulin dose if Kerendia is added to the treatment of a patient on insulin.
The company also reported results from a second phase III trial, FIGARO-DKD: in a broad patient population with stage 1-4 chronic kidney disease (CKD) and type 2 diabetes, when combined with standard of care, compared with placebo Kerendia reduces cardiovascular (CV) prognostic risk.
Analysts believe the drug could have annual sales of $2 billion or more if the label is expanded to reflect the FIGARO-DKD data and other potential indications, such as non-diabetic CKD and heart failure, for which research is ongoing. In Phase III testing:
In November 2021, Bayer announced the initiation of the FIONA clinical study, a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating in approximately 200 pediatric patients with severely increased CKD and proteinuria at standard Efficacy, safety, and pharmacokinetics/pharmacodynamics of feneridone on a therapeutic basis.
In September 2021, Bayer announced the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to explore the use of feneridone in the treatment of non-diabetic CKD.
The FIND-CKD study enrolled more than 1,500 patients with non-diabetic CKD, including hypertensive nephropathy and chronic glomerulonephritis (inflammation of the kidneys), to explore the efficacy and safety of adding feneridone to guideline-recommended therapy.
In June 2020, Bayer announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study that included more than 5,500 patients with preserved ejection fraction (left ventricular ejection fraction ≥40 %) in patients with symptomatic heart failure (New York Heart Association class II-IV).
The primary objective of the study was to demonstrate that feneridone was superior to placebo in reducing the rate of the composite end point of cardiovascular death and overall (first and recurrent) heart failure events (defined as hospitalization for heart failure or emergency visits for heart failure).
In addition, in February 2022, Bayer announced the initiation of the CONFIDENCE study, a Phase II, three-arm study that will study feneridone and the SGLT2 inhibitor empagliflozin concomitantly in patients with CKD and type 2 diabetes, respectively. Combination therapy, compared with feneridone alone and empagliflozin alone.
The primary objective of the study was to demonstrate that simultaneous initiation and combination of fennelidone and empagliflozin was superior to either empagliflozin alone or fenaridone alone in reducing urinary albumin-to-creatinine ratio (UACR).
Reference:
Bayer corporate announcement, etc.
Bayer Kerendia for type 2 diabetes-related chronic kidney disease (CKD) approved in China
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