Less than a month after announcing success in a late-phase trial, Bayer has unveiled detailed results from its drug Kerendia in a subset of people with heart failure, sparking plans for a regulatory filing that could significantly boost the treatment’s market prospects.
The mineralocorticoid receptor antagonist won FDA approval in 2021 to reduce the risk of certain kidney and heart events in patients with chronic kidney disease associated with type 2 diabetes. But Bayer is seeking a label expansion to reach a broader group of patients.
In the Phase 3 trial’s composite primary endpoint, Kerendia achieved a 16% relative risk reduction in cardiovascular death and total heart failure events versus placebo over a median duration of 32 months (p=0.0072), according to data presented Sunday at the European Society of Cardiology annual meeting in London. Heart failure events were defined as hospitalizations for heart failure or urgent heart failure visits, the company said.
The FINEARTS-HF trial set Kerendia against placebo in more than 6,000 people with heart failure and left ventricular ejection fraction (LVEF) of at least 40%, all of whom also received standard-of-care treatment. Earlier this month, Bayer said the trial met its primary endpoint but didn’t disclose p-values or other figures.
Heart failure affects more than 60 million people worldwide, around half of whom have at least 40% LVEF, according to Bayer.
The 16% risk reduction was consistent across all 17 pre-specified subgroups in the trial, including patients who had just been discharged from hospital and those who were taking an SGLT2 inhibitor at baseline, Bayer’s senior global medical affairs physician Katja Rohwedder told Endpoints News in an interview.
SGLT2 drugs such as Eli Lilly and Boehringer Ingelheim’s Jardiance and AstraZeneca’s Farxiga are often used to treat heart failure. The fact that Kerendia was able to boost cardiac outcomes in patients already taking those drugs could help establish it as a “foundational pillar” of treatment, Rohwedder said.
In the secondary endpoints, Kerendia reduced total heart failure events (p=0.0062) and improved patient-reported health status as measured from baseline (p<0.0001).
Bayer said it plans to file for a US label expansion “in due course.” In the second quarter, Kerendia sales were up 71% from the same period in 2023 to €115 million ($127.7 million), according to the company.
Last year, GlobalData analysts said Kerendia could hit sales of €1.7 billion ($1.9 billion) in 2029. But the path to label expansion has not been without its setbacks. In 2022, a pooled analysis from a pair of Phase 3 trials of Kerendia showed the drug didn’t significantly reduce all-cause or cardiovascular mortality among patients with diabetic kidney disease.
Heart failure remains a big part of Bayer’s vision for the therapy. To thoroughly test for its potential, Bayer has expanded the registrational heart failure program for Kerendia to include three new studies enrolling a total of 9,000 patients. Those studies are testing the drug in people with reduced (HfrEF), mildly reduced (HfmrEF) and preserved (HfpEF) ejection infractions, respectively.