Bayer’s cardiovascular drug shows impressive Phase III results
pharmafile | May 11, 2021 | News story | Manufacturing and Production | Bayer, chronic kidney disease, pharma, pharma news, type 2 diabetes
Bayer’s finerenone drug has been shown to significantly reduce cardiovascular death or other cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), according to results from a Phase III trial.
The randomised FIGARO-DKD Phase III study investigated finerenone versus placebo in around 7,400 patients with CKD and T2D worldwide, and found that the drug substantially reduced the risk of myocardial infarction, stroke, or heart failure hospitalisation, as well as death.
Patients were randomised to receive either 10 mg or 20 mg of finerenone orally once daily, or placebo, when added to standard of care.
Finerenone could become the first non-steroidal, selective mineralocorticoid receptor antagonist to demonstrate renal and cardiovascular benefits in patients with CKD and T2D. Patients with CKD and T2D are currently around three times more likely to die from a cardiovascular-related cause than those with T2D alone.
Based on positive data from the previously completed Phase III FIDELIO-DKD study, Bayer have already submitted a marketing authorisation application to the EMA, as well as a new drug application to the FDA, which was accepted for Priority Review.
An estimated 160 million patients globally are living with CKD and T2D, putting them at high risk of experiencing cardiovascular events, as well as progressing to kidney failure.
Prof Luis M Ruilope, Co-Principal Investigator of the FIGARO-DKD trial, said: “The FIGARO-DKD study delivers important insights into the cardiovascular benefits of finerenone, suggesting its potential to offer physicians a new tool in their armamentarium to protect these vulnerable patients by reducing their risk of cardiovascular events.”
Dr Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development, added: “With the positive outcome of the composite primary endpoint of the FIGARO-DKD trial, we have reached a significant milestone by completing the largest Phase III clinical trial program to date focusing on CKD and T2D across a broad range of disease severity.
“We are pleased to see that the FIGARO-DKD data further support the evidence generated in the FIDELIO-DKD trial with respect to reducing the combined risk of cardiovascular death or non-fatal cardiovascular outcomes in patients with CKD and T2D.”
Jack Goddard
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