Bayer DE000BAY0017 is now permitted to market the drug Finerenone in the USA for a specific form of heart failure.

The US Food and Drug Administration (FDA) has approved the drug, branded as Kerendia, for the treatment of adults with heart failure with a left ventricular ejection fraction of at least 40 percent, the pharmaceutical and agrochemical company announced on Monday. The move had been expected. Corresponding applications for approval in other major markets, such as the EU, China, and Japan, are still pending.

Kerendia is approved in many countries worldwide for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in adults. The drug is intended to help reduce the risk of end-stage kidney disease, cardiovascular death, and non-fatal heart attack, among other benefits.

In 2024 alone, sales of the relatively new drug grew by more than 70 percent to €463 million, which is still quite low relative to the pharmaceutical division's total sales. In the longer term, the DAX-listed company expects peak annual sales of €3 billion, which should help at least partially offset losses from blockbusters such as the blood thinner Xarelto and the eye medication Eylea. Especially for Xarelto, competition from generics due to patent expirations is already putting pressure on the billion-dollar revenue; a similar picture is likely to emerge for Eylea in the future.