Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure.
In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure.
Kerendia is a small molecule designed to block the mineralocorticoid receptor, which plays a role in blood pressure regulation. The first drugs developed to block this receptor are corticosteroids. Kerendia, a non-steroidal drug, was initially approved by the FDA in 2021 as a treatment for chronic kidney disease in patients with type 2 diabetes. The approval specifically covers the reduction in the risk of kidney function decline, kidney failure, or cardiovascular problems — including hospitalization for heart failure — in these patients.
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In 2023, Bayer reported €270 million in sales for Kerendia, a 152% increase over its sales in 2022. Bayer has touted the once-daily pill’s blockbuster potential as a treatment for both kidney disease and heart failure.
The placebo-controlled Phase 3 test in heart failure enrolled about 6,000 patients with a diagnosis of symptomatic heart failure with left ventricular ejection fraction (LVEF) of 40% or lower. LVEF is a measure of how much blood is pumped out of the heart’s left ventricle. The lower the LVEF percentage, the less blood is pumped out to the rest of the body. The 40% mark is below the normal range and can be a sign of heart failure. The main goal of the study is a composite of cardiovascular death and total heart failure events, defined as hospitalizations for heart failure or urgent heart failure visits.
Patients in the heart failure trial received the study drug for up to 42 months. No details about Kerendia’s safety were disclosed. Bayer only said no new safety signals were identified compared with those seen in previous studies. Kerendia’s current label includes a warning for hyperkalemia, which is elevated potassium levels in the blood.
“Bayer is determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical need, including for patients with mildly reduced or preserved ejection fraction,” Christian Rommel, head of research and development at Bayer’s Pharmaceuticals Division, said in a prepared statement.
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The 6,000-patient heart failure trial is part of a broader Bayer clinical development program for Kerendia projected to enroll about 15,000 patients across four total studies in heart failure. The additional studies underway are evaluating Kerendia as a treatment for hospitalized or recently discharged heart failure patients; in combination with an SGLT2 inhibitor, which is a blood sugar-lowering type 2 diabetes drug, in hospitalized or recently discharged heart failure patients; and in heart failure patients intolerant to or ineligible for treatment with a steroidal drug.
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