Bayer gains first approval for its CKD therapy Kerendia

The US Food and Drug Administration has approved under priority review Kerendia (finerenone), the first and only non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), German pharma major Bayer (BAYN: DE) announced late Friday.

The approval is based on the results of the pivotal Phase III FIDELIO-DKD trial data that demonstrated positive kidney and cardiovascular outcomes in patients with CKD and T2D, published in the  New England Journal of Medicine in October 2020, and follows priority review designation granted by the FDA.

Bayer said that Kerendia, which has a US list price of $19 per day before discounts and patient assistance programs, is expected to be available in the USA beginning the end of July 2021. Finerenone has also been submitted for marketing authorization in the European Union.