CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes.- Bayer Healthcare.
Finerenone (10 mg or 20 mg) is recommended for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
“Despite currently available treatment options, many patients with chronic kidney disease associated with type 2 diabetes progress to kidney failure or premature death. These patients have a critical need for treatment options that can delay kidney disease progression and reduce the risk of cardiovascular events,” said Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen. “Once approved, finerenone will be the first non-steroidal MR antagonist to offer adult patients living with chronic kidney disease associated with type 2 diabetes a new therapy to help improve kidney outcomes.”
The positive CHMP opinion is based on the results of the pivotal Phase III FIDELIO-DKD study, presented at the American Society of Nephrology’s (ASN) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020 ( previously cited).
In July 2021, finerenone was approved under the brand name Kerendia by the FDA based on the positive results of the FIDELIO-DKD Phase III study for adult patients with CKD and T2D. Finerenone has also been submitted for marketing authorization in China and multiple other countries worldwide; these applications are currently under review.
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