While Bayer’s Kerendia can’t match the efficacy figures of other chronic kidney disease (CKD) drugs such as AstraZeneca’s Farxiga, the company believes there’s a market for it as a complementary treatment as it falls into a different drug class.
Since its FDA approval last July to treat patients with CKD associated with type 2 diabetes, Bayer has continued to post data that demonstrate the benefits of Kerendia.
Another example came this weekend when Bayer showed that Kerendia cut the incidence of sudden cardiac death across a broad range of patients with early- to late-stage CKD and diabetes. The result came from a prespecified, pooled analysis of certain patients in the Fidelio-DKD and Figaro-DKD studies.
While Kerendia narrowly missed the statistical significance bar for cutting all-cause and cardiovascular mortality in the overall study populations, a prespecified analysis of patients with CKD and type 2 diabetes was more favorable for the drug.
In the analysis, Kerendia cut the risk of sudden cardiac death by 25% versus placebo. The med cut the risk of death from any cause by 18% versus placebo. It also cut the risk of death from a cardiovascular event by 18%.
Investigators presented the results during the European Society of Cardiology congress in Spain.
Many patients with the conditions “progress to kidney failure and are at a significantly increased risk of cardiovascular death,” Bayer’s R&D head Christian Rommel said in a statement. The analysis shows the drug potential to “reduce the risk of mortality amongst this vulnerable patient population, and keep them healthier for longer.”
As opposed to a heart attack, when blood flow to the heart is blocked, sudden cardiac arrest is when the heart malfunctions and stops beating unexpectedly. Roughly 356,000 people have sudden cardiac arrest each year in the United States and only about 10% survive.
Kerendia is the first nonsteroidal mineralocorticoid receptor antagonist (MRA) approved for chronic kidney disease. The medicine blocks the production of steroids in the body that degrade heart function and lead to kidney damage spurred by fibrosis and inflammation.
Bayer has predicted the drug can haul in 1 billion euros in peak annual sales.
Bayer also hopes to expand Kerendia’s use into nondiabetic patients. In 2020, Bayer launched a phase 3 trial of patients with heart failure with preserved ejection fraction.