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Bayer Submits Indication Expansion Application for Feneridone in Patients with Early-Stage Chronic Kidney Disease and Type 2 Diabetes in the EU

 Last Update: 2022-04-28
 Source: Internet
 Author: User

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On March 16, 2022, Bayer announced that it had submitted a Category II change application to the European Medicines Agency to seek to expand the indication of feneridone to cover patients with early-stage chronic kidney disease and type 2 diabetes
.

The filing is based on positive data from the FIGARO-DKD study, which showed that feneridone significantly reduced the risk of cardiovascular events in adults with chronic kidney disease and type 2 diabetes
.
The FIGARO-DKD study included patients with various disease severities, including stage 1-4 chronic kidney disease with type 2 diabetes
.
The findings were presented at the 2021 European Society of Cardiology Congress and published simultaneously in the New England Journal of Medicine
.
The FIDELIO-DKD and FIGARO-DKD studies are part of the largest Phase III clinical trial program to date in patients with chronic kidney disease and type 2 diabetes showing positive kidney and cardiovascular outcomes
.

"Many patients with chronic kidney disease and type 2 diabetes are progressing to renal failure or die prematurely," said Dr.
Christian Rommel, Member of the Executive Committee of Bayer's Prescription Medicines Division and Director of Research and Development
.
Burden is important, and the FIGARO-DKD study covers patients with early-stage chronic kidney disease and demonstrates the cardiovascular benefit of feneridone in patients with various disease severities
.
”

Based on positive results from the FIDELIO-DKD Phase III clinical study, February 2022, Feneridone is approved in the European Union for the treatment of adult patients with chronic kidney disease (stages 3 and 4 with albuminuria) associated with type 2 diabetes
.
In July 2021, Feneridone received FDA approval to reduce the risk of persistent decline in eGFR, end-stage renal disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease and type 2 diabetes
.
Bayer has submitted feneridone marketing applications in several countries and is currently under review
.

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