Bayer Presents Pooled Phase 3 Data Showing Kerendia Significantly Reduces Cardiovascular and Kidney Risks in Patients with Type 2 Diabetes and Chronic Kidney Disease
Bayer
Pharmaceutical Product R&D Developer
American College of Cardiology
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and treatment outcomes. As the professional home for the entire cardiovascular care team, the College and its more than 54,000 members are dedicated to transforming cardiovascular care and improving heart health. The ACC awards credentials to qualified cardiovascular professionals and leads the development of health policies, standards, and guidelines. The College also provides continuing medical education, disseminates cardiovascular research through its world-renowned JACC journals, operates national registries to evaluate and improve care, and offers cardiovascular accreditation for hospitals and institutions.
Compiled by Fan Dongdong
Recently, at the American College of Cardiology conference held in Washington, Bayer presented positive data for its kidney disease drug Kerendia (finerenone).
Bayer's Latest Published Kerendia Dataset Combines Data from Two Phase 3 Trials Involving 13,000 Patients Across 48 Countries
Trial results show that Bayer's Kerendia reduced the risk of severe cardiac and renal outcomes in patients, regardless of whether they had a history of heart disease. Moreover, the reduction in risk was greater for patients with a history of heart disease. During the median follow-up period of 3 years, the cardiac event rate was 6.9 events per 100 patient-years in patients with cardiovascular disease, compared to 3 events in patients without a history of cardiovascular disease. The risk of kidney disease showed similar results.
In July last year, Kerendia was approved by the U.S. FDA for marketing to treat adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. This drug is also the first non-steroidal mineralocorticoid receptor antagonist (MRA) approved for the treatment of patients with chronic kidney disease. Previous trials have shown that Kerendia can significantly slow the progression of chronic kidney disease and reduce cardiovascular risks in patients with chronic kidney disease associated with type 2 diabetes.
It is reported that Bayer's Kerendia can reduce the harmful effects caused by the overactivation of mineralocorticoid receptors and indirectly protect patients' damaged hearts and kidneys. Although Kerendia is considered a competitor to SGLT2 kidney disease treatment drugs (such as Johnson & Johnson's Invokana and AstraZeneca's Farxiga), trial data from Figaro shows that Kerendia can effectively be used in combination with SGLT2 drugs, enhancing the therapeutic benefits for the heart and kidneys.
Regarding the sales peak of Kerendia, Bayer forecasts it will reach 1 billion euros. The company also anticipates that Kerendia’s market launch will offset the future generic competition faced by its blockbuster products Eylea and Xarelto. Additionally, Bayer aims to expand Kerendia's application to non-diabetic patients. To this end, Bayer initiated a targeted Phase 3 trial in 2020 among patients with heart failure with preserved ejection fraction.
Meanwhile, in another presentation at the American College of Cardiology, Bayer reported that a Phase 2 clinical trial showed that the thrombosis prevention drug asundexian reduced bleeding or stroke by 67% in patients at risk of atrial fibrillation. In February this year, the U.S. FDA granted asundexian Fast Track designation, and the drug is currently in regulatory competition with Johnson & Johnson and Bristol-Myers Squibb's Xia factor inhibitor drugs.
Source: ACC: Bayer's Kerendia Reduces Cardio and Kidney Complications in High-Risk Patients
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