Benzinga | Jul 12, 2021 07:11AM EDT

Bayer's Kerendia Scores Long-Awaited Kidney & Heart Disease Nod For Type 2 Diabetes

* The FDA on Friday approved Bayer AG's (OTC:BAYRY) chronic kidney disease (CKD) drug Kerendia (finerenone), the first and only nonsteroidal mineralocorticoid receptor antagonist.

* Finerenone is indicated to reduce the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks, and hospitalization for heart failure in patients with chronic kidney disease associated with Type 2 diabetes.

* In its approval, the FDA cited Bayer's 5,600-person late-stage trial, which found Kerendia beat placebo when it came to kidney function. That included fending off kidney failure when patients need dialysis or a transplant to survive, death from kidney disease, or a slowing decline in the rate at which the kidneys could filter blood.

* That trial found Kerendia also reduced the composite risk of time to the first occurrence of cardiovascular death or nonfatal heart attack, stroke, or hospitalization for heart failure over placebo.

* Kerendia will now face off against the established SGLT2 inhibitors, AstraZeneca plc's (NASDAQ:AZN) Farxiga and Johnson & Johnson's (NYSE:JNJ) Invokana.

* Invokana won approval to treat diabetic kidney disease back in 2019, while in April, Farxiga scored an FDA nod to treat kidney disease patients regardless of whether they have diabetes.

* Kerendia will be commercially available in the U.S. by the end of July.

* Finerenone has also been submitted for marketing authorization in the European Union.

* Price Action: BAYRY shares closed at $15.15 on Friday.

* Related content: Benzinga's Full FDA Calendar.