Bayer's Kerendia Gets FDA Priority Review for Label Expansion

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental New Drug Application (sNDA) to expand the label of Kerendia (finerenone) to include patients with chronic kidney disease (CKD) associated with type I diabetes. The decision follows strong phase III data.

Details of the Regulatory Action

The FDA granted Priority Review status to Bayer's sNDA for Kerendia, reducing the review timeline from the standard 10 months to 6 months. The drug is currently approved for CKD in patients with type II diabetes.

Company's Position

Bayer expressed confidence in the clinical trial data, which demonstrated Kerendia's efficacy in slowing CKD progression in type I diabetes patients. The company believes approval would significantly expand the eligible patient population.

Precedents and Context

Kerendia initially received FDA approval in July 2021 for CKD in type II diabetes patients. Since then, the drug has seen growing sales, but faces competition from SGLT2 inhibitors like Jardiance (Eli Lilly) and Farxiga (AstraZeneca).

Potential Financial Impact

If approved, the label expansion could substantially boost Kerendia's revenue, as millions of type I diabetes patients with CKD worldwide could become eligible. However, Bayer has not provided specific financial guidance.