The U.S. Food and Drug Administration (FDA) has granted Priority Review for finerenone, an experimental drug manufactured by the Bayer Corporation for people living with chronic kidney disease (CKD) and type 2 diabetes (T2D), as the company announced in January.* This decision was based on the results of the Phase III FIDELIO-DKD clinical trial, published in the October 23, 2020, edition of the New England Journal of Medicine.

What is finerenone?

Finerenone is a potential first-in-class, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). MRA drugs block the effects of aldosterone, a hormone produced in the cortex of the adrenal gland. Aldosterone helps balance water, sodium, and potassium, but too much aldosterone can result in water and sodium retention. Finerenone demonstrated beneficial kidney and cardiovascular effects in patients with CKD and T2D in the Phase III study.

What does Priority Review mean?

Under a Standard Review, the FDA takes action within 10 months of accepting a New Drug Application (NDA). Granting finerenone Priority Review indicates the agency’s intention to take action within six months of accepting Bayer’s NDA. A Priority Review designation is granted to drugs with the potential to have considerable positive impacts on the prevention, diagnosis, or treatment of serious conditions.

How does this affect patients?

“There is currently a significant unmet medical need for the nearly 40% of people in the U.S. living with type 2 diabetes who will develop chronic kidney disease,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer. “Based on study data, finerenone offers a potential new strategy to delay CKD progression, while reducing the risk of cardiovascular events. We’re encouraged that the FDA has granted the NDA a Priority Review, as it potentially expedites our ability to make finerenone available to patients.”

*PBR Staff Writer. (2021, Jan. 13). Bayer Announces FDA Accepts NDA and Grants Priority Review for Finerenone for Patients with CKD and T2D. Pharmaceutical Business Review. https://www.pharmaceutical-business-review.com/news/bayer-announces-fda-accepts-nda-and-grants-priority-review-for-finerenone-for-patients-with-ckd-and-t2d/