The Bayer Kerendia blockbuster widens its FDA approval to the type of heart failure

A bayer medication that the company supervises as a key to developing its cardiovascular portfolio has expanded its FDA approval to a type of heart failure, a new indication that maintains this pill on the way for the completion of sales of superproductions to compensate for the drop in revenues of the global product of Xarelto, now confronted with patent expirations.

Bayer said on Monday that the FDA approved Kerendia for treating heart failure with a slightly reduced, or HFMREF ejection fraction. Approval specifically covers patients whose left ventricular ejection fraction (LVEF) is measured at 40% or more. Leve, how many blood the pumps at each heart rate, are measured as a percentage. The normal beach is between 50% and 70%. But as this percentage falls into the HFMREF range from 40% to 49%, a patient faces a higher risk of developing heart failure.

Older cardiovascular drugs are available for the treatment of patients with HFMREF. But Bayer says that around 3.7 million adults in the United States with a slightly reduced ejection fraction faced with high risks of hospitalization for heart failure. Kerendia presents a new approach to deal with the condition.

Kerendia is a small non -steroidal and oral molecule designed to block the mineralocorticoid receptor, stopping excessive activation of this receptor which contributes to fibrosis and inflammation. The drug, taken as a pill once a day, was approved for the first time in 2021 to reduce the risk of decrease in kidney function and hospitalization for heart failure in patients with chronic kidney disease associated with type 2 diabetes.

Within his pharmaceutical division, Bayer identified cardiovascular indications as one of the four basic therapeutic areas for the company. The others are oncology; neurology and rare diseases; and immunology. Xarelto, an anticoagulant with regulatory approvals in several cardiovascular indications, is Bayer’s best overall product, which represents 3.4 billion euros in sales in 2024. But this figure is a decrease of 14.7% compared to the previous year. The patents for Xarelto have started to expire and the product is already faced with generic competition in certain markets. Like its large pharmaceutical peers, Bayer must find other products to compensate for the drop in income from products that fall on the patent cliff.

Bayer declared 463 million euros (around $ 539.9 million) in sales of Kerendia in 2024, an increase of more than 71% compared to sales of the previous year. In its annual report, Bayer has awarded a large part of the increase in product growth in the United States and China. In the first quarter of this year, Bayer said 161 million euros (around $ 187.7 million) in Kerendia income, an increase of 87% compared to the same period in 2024. Bayer also identified the Nubeqa prostate cancer drug as a key engine of future income growth.

“Nubeqa and Kerendia continued their exceptional momentum,” said CEO Bill Anderson at a conference call in May to discuss the financial results of the first quarter of 2025. “Together, they increased by 80% in annual shift. These earn more than compensating for the drops we see on Xarelto. ”

The new approval of the FDA of Kerendia is based on the results of a phase 3 test controlled by placebo in heart failure. The main objective was a composite measure of cardiovascular death and total heart failure events, defined as hospitalizations for heart failure or urgent heart failure. The study recruited approximately 6,000 patients assigned to random to receive Kerendia or a placebo up to 42 months. All participants continued to take the other heart failure drugs they used before starting the clinical trial.

The test results have shown that the participants treated with Kerendia have experienced a lower rate of composite heart failure and death in placebo. This lower rate was statistically significant. The detailed results of the Pivot study were published last September in the New England Journal of Medicine.

“Even with current treatments, 21% of patients with symptomatic heart failure are transforming hospitalization for heart failure or [cardiovascular] Death, and 25% who know hospitalization is readmitted due to heart failure in the year following the exit, “said Alanna Morris-Simon, main medical director of American medical affairs in Bayer, in a prepared statement.” Now, as a main treatment pillar, Kerendia can help patients reduce these risks. “”

Bayer photo