Naphthyridines

Bayer’s Finerenone Meets Primary Endpoint in Phase III FIGARO-DKD Cardiovascular Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

Retrieved on: 
Monday, May 10, 2021

b'Bayer\xe2\x80\x99s Phase III cardiovascular outcomes study FIGARO-DKD, evaluating the efficacy and safety of the investigational drug finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) has met its primary endpoint.

Key Points: 
  • b'Bayer\xe2\x80\x99s Phase III cardiovascular outcomes study FIGARO-DKD, evaluating the efficacy and safety of the investigational drug finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) has met its primary endpoint.
  • Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial.
  • Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial.
  • Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging.

Bayer Announces U.S. FDA Accepts New Drug Application and Grants Priority Review for Investigational Drug Finerenone for Patients with Chronic Kidney Disease and Type 2 Diabetes

Retrieved on: 
Tuesday, January 12, 2021

Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

Key Points: 
  • Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
  • Were encouraged that the FDA has granted the NDA a Priority Review, as it potentially expedites our ability to make finerenone available to patients.
  • The FDA grants Priority Review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition.
  • Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging.

Bayer Presents FIDELIO-DKD Phase III Study Cardiovascular Subgroup Analysis of Patients With Chronic Kidney Disease and Type 2 Diabetes

Retrieved on: 
Tuesday, November 17, 2020

In this pre-specified exploratory subgroup analysis of FIDELIO-DKD study of finerenone, researchers evaluated the secondary composite CV outcomes by patient history of CVD (Interaction p-0.85).

Key Points: 
  • In this pre-specified exploratory subgroup analysis of FIDELIO-DKD study of finerenone, researchers evaluated the secondary composite CV outcomes by patient history of CVD (Interaction p-0.85).
  • These findings underscore the life-threatening connection between chronic kidney disease and cardiovascular disease.
  • Phase III data from the FIDELIO-DKD study were presented in October at the American Society of Nephrologys (ASN) Kidney Week 2020, and simultaneously published in the New England Journal of Medicine.
  • Based on these data, Bayer submitted applications for marketing authorization of finerenone in the U.S. and the EU.

Drug Study Offers New Hope to Patients with Both Chronic Kidney Disease and Type 2 Diabetes

Retrieved on: 
Friday, October 23, 2020

"This is an exciting and promising discovery for patients with chronic kidney disease and type 2 diabetes," said one of the study investigators, Dr. Rajiv Agarwal.

Key Points: 
  • "This is an exciting and promising discovery for patients with chronic kidney disease and type 2 diabetes," said one of the study investigators, Dr. Rajiv Agarwal.
  • "Blocking the renin-angiotensin system (RAS) has been the backbone of treatment of patients with diabetes and chronic kidney disease (CKD).
  • The FIDELIO-DKD study performed in 5,734 patients with advanced kidney disease and type 2 diabetes showed that finerenone protected both the heart and the kidneys.
  • A sister study of FIDELIO-DKD called FIGARO-DKD is being performed in even an earlier stage of kidney disease.

Bayer’s FIDELIO-DKD Phase III Study Demonstrated Investigational Drug Finerenone Significantly Reduced Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Retrieved on: 
Friday, October 23, 2020

Bayer announced today that detailed results from the FIDELIO-DKD Phase III study demonstrated that the investigational drug finerenone slowed the progression of chronic kidney disease (CKD) in patients with CKD and type 2 diabetes (T2D) compared to placebo.

Key Points: 
  • Bayer announced today that detailed results from the FIDELIO-DKD Phase III study demonstrated that the investigational drug finerenone slowed the progression of chronic kidney disease (CKD) in patients with CKD and type 2 diabetes (T2D) compared to placebo.
  • The FIDELIO-DKD results demonstrate that finerenone may become a new potential therapeutic option for patients with chronic kidney disease and type 2 diabetes.
  • The frequency of serious adverse events was lower in patients treated with finerenone (31.9 percent) compared to placebo (34.3 percent).
  • Overall hyperkalemia-related adverse events occurred more often in patients receiving finerenone compared with placebo (18.3 percent and 9 percent, respectively).

Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

Retrieved on: 
Thursday, July 9, 2020

Bayer today announced the Phase III study FIDELIO-DKD, which is evaluating the efficacy and safety of finerenone versus placebo when added to standard of care for chronic kidney disease (CKD) in patients with type 2 diabetes (T2D), has met its primary endpoint.

Key Points: 
  • Bayer today announced the Phase III study FIDELIO-DKD, which is evaluating the efficacy and safety of finerenone versus placebo when added to standard of care for chronic kidney disease (CKD) in patients with type 2 diabetes (T2D), has met its primary endpoint.
  • FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study investigating finerenone versus placebo in patients with CKD and T2D.
  • There has been a recent uptick of both federal initiatives and public-private partnerships encouraging innovation to improve kidney health in America.
  • FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D.

Finerenone (Bayer) Overview and Drug Profile 2019 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 25, 2019

Finerenone (Bayer) is a third-generation potent and selective oral, non-steroidal mineralocorticoid receptor antagonist (MRA).

Key Points: 
  • Finerenone (Bayer) is a third-generation potent and selective oral, non-steroidal mineralocorticoid receptor antagonist (MRA).
  • Finerenone was designed to have advantages over these current MRAs, with an improved benefit/risk profile, although patients with heart failure are being excluded from its placebo-controlled trials because MRAs are already recommended for that indication.
  • Finerenone is currently in Phase III development in the US, Japan, and EU as an add-on therapy to renin-angiotensin system inhibitors in DN (ClinicalTrials.gov identifiers: NCT02545049 and NCT02540993).
  • Both Phase III trials include renal and cardiovascular (CV) outcomes, but one has renal outcomes as the primary endpoint and the other has CV outcomes.