Bayer's Kerendia Cuts Cardiovascular Risk by 16%

Bayer's pharmaceutical division has announced promising new data regarding their drug Kerendia (finerenone), which is projected to generate $3 billion in peak sales. Initially approved in 2021 for treating chronic kidney disease associated with type 2 diabetes, Kerendia is now showing significant benefits in a broader patient population. Recently, results from the Phase III FINEARTS-HF trial indicated that Kerendia reduced the risk of cardiovascular death and heart failure by 16%.

The FINEARTS-HF trial, which involved approximately 6,000 patients across 630 sites in 37 countries, was designed to evaluate the efficacy of Kerendia in patients with heart failure and mildly reduced or preserved ejection fraction. These patients were randomly assigned to receive either Kerendia or a placebo, in addition to their existing treatments for managing symptoms and comorbidities. The study's primary endpoint was a composite measure of cardiovascular death and total heart failure events, including hospitalizations and urgent care visits.

Bayer's data indicate that Kerendia significantly reduced the risk of cardiovascular death and heart failure events over a median follow-up period of 32 months. Importantly, the drug also satisfied secondary endpoints by reducing total heart failure events and improving patient-reported outcomes. The benefits of Kerendia were consistent across all prespecified subgroups, regardless of background therapy, other health conditions, or prior hospitalization status.

The findings were presented at the ESC Congress 2024 and simultaneously published in the New England Journal of Medicine, reinforcing the credibility and importance of the results. According to Christian Rommel, head of research and development at Bayer's pharmaceuticals division, the data confirm Kerendia's potential as a valuable treatment option for heart failure patients with mildly reduced or preserved ejection fraction. Rommel emphasized that the drug's effectiveness was evident regardless of the patients' background therapy or disease state.

Kerendia's initial launch in the kidney disease market did not meet sales expectations, prompting Bayer to refocus its strategy on the heart failure market, which they believe holds greater potential. Stefan Oelrich, head of Bayer's pharmaceuticals unit, expressed confidence during an earnings call in May that targeting heart failure would enable the company to achieve its $3 billion peak sales goal.

Bayer's broader clinical program for Kerendia in heart failure, known as MOONRAKER, includes around 15,000 patients, underscoring the company's commitment to exploring the full potential of the drug. The ongoing research aims to further delineate Kerendia's benefits and solidify its role in treating heart failure patients.

Detlef Voigt, another key figure in Bayer's efforts, is instrumental in advancing Kerendia's clinical program. The company's strategy to expand the drug's indications highlights their dedication to addressing significant unmet medical needs in cardiovascular health.

In summary, Bayer's new data on Kerendia offers hope for improved treatment outcomes in heart failure patients with mildly reduced or preserved ejection fraction. The drug's ability to reduce cardiovascular death and heart failure events marks an important milestone in Bayer's efforts to position Kerendia as a leading therapy in the heart failure market.

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