Bayer has announced new positive interim results from a Phase IV real-world trial investigating Kerendia (finerenone) to treat patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
The FINE-REAL observational study (NCT05348733) evaluated the clinical characteristics and treatment patterns of 504 patients with CKD and T2D treated with Kerendia. The results were presented at the American Society of Nephrology’s (ASN) Kidney Week in Philadelphia from 2 to 5 November 2023.
The interim results indicate that in real-world clinical practice, the incidence rate of hyperkalaemia, (high blood potassium levels), among patients taking Kerendia was 5%. This was lower than what was observed in the pivotal trials of the drug, where 14% of patients on Kerendia reported hyperkalaemia.
The study also showed that healthcare providers are starting to use the drug earlier in the disease progression, especially for patients with a moderate risk.
The drug gained US Food and Drug Administration (FDA) approval in 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, non-fatal myocardial infarction, and hospitalisation for heart failure (HF) in adult patients with CKD associated with T2D.
Bayer cardiovascular and renal vice-president Robert Perkins said: “These interim results from the FINE-REAL study provide new insight into Kerendia’s real-world clinical use and safety information on how patients and their healthcare teams are integrating Kerendia.”
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In September 2023, Bayer added three investigator-sponsored Phase III clinical trials evaluating Kerendia for the treatment of heart failure.
Kerendia generated €67m ($72.04m) worth of sales in Q2 2023, according to the company’s half-year report. GlobalData forecasts that sales of Kerendia will exceed $1.7bn in 2029.
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