Bayer's blockbuster hopeful Kerendia extends its FDA approval to the type of heart failure
Bayer Pharmaceuticals, key to increasing its cardiovascular portfolio, expanded its FDA approval to a heart failure, a new sign that keeps the pill on the road to achieving blockbuster sales to help offset the decline in revenues of the highest product, Xarellto, now faces the expiration of pensions.
Bayer said Monday that the FDA approved Kerendia for treatment of heart failure with mildly reduced ejection fraction or HFMREF. This approval specifically covers patients with their left ventricular ejaculation fraction (LVEF), measured at 40% or higher. LVEF is the pumping amount of blood for each heartbeat, which is considered a percentage. The normal range is between 50% and 70%. However, as this percentage drops to the HFMREF range of 40% to 49%, patients are at greater risk of heart failure.
Older cardiovascular drugs can be used to treat patients with HFMREF. But despite these treatments, Bayer said that about 3.7 million adults in the U.S. have slightly reduced ejaculation fraction, but the risk of hospitalization due to heart failure remains high. Kerendia has introduced a new way to treat the condition.
Kerendia is a nonsteroidal oral small molecule designed to block the mineral corticosteroid receptor and stop overactivating the receptor, which is believed to cause fibrosis and inflammation. The drug, considered once a day, was first approved in 2021 to reduce the risk of decreased renal function and hospitalization in patients with chronic kidney disease associated with type 2 diabetes.
Within its pharmaceutical division, Bayer identified cardiovascular signs as one of the company's four core therapeutic areas. Others are oncology; neurology and rare diseases; and immunology. Xarelto is a regulatory-approved anticoagulant with several cardiovascular signs, and is Bayer's highest overall product that accounts for €3.4 billion in 2024 sales. But that number fell 14.7% from the previous year. Xarelto's patent has begun expiration and the product is already facing general competition in certain markets. Like its big pharma companies, Bayer needs to find other products to compensate for the decline in revenues of drugs that fall on the patent cliff.
Bayer reported sales of Kerendia in 2024 of €463 million (about $539 million), up more than 71% from the previous year’s sales. In its annual report, Bayer attributed much of its revenue to growth in U.S. and Chinese products. In the first quarter of this year, Bayer reported €161 million (about $187.7 million) in Kerendia's revenue, an 87% increase compared to the same period in 2024. Bayer also identified the prostate cancer drug Nubeqa as a key driver of future revenue growth. The company expects Clundia and Nobca to sell at a peak of 3 billion euros (about $3.5 billion) per person.
CEO Bill Anderson discussed the first quarter of 2025 financial results on a May conference call. “Together they grew 80% year-on-year. These gains far offset the decline we're seeing on Xarelto.”
Kerendia's new FDA approval is based on the results of a placebo-controlled Phase 3 test. The primary goal is a comprehensive measure of cardiovascular death and total heart failure events defined as hospitalization for heart failure or emergency heart failure visits. The study recruited approximately 6,000 randomly assigned patients to receive Kerendia or placebo for up to 42 months. All participants continued to use other heart failure drugs before starting the clinical trial.
The trial results showed that participants treated with Kerendia had lower combined heart failure events and mortality compared to placebo. The lower rate was statistically significant. The detailed results of the key study were published in the New England Journal of Medicine last September.
“Even with current treatment, 21% of patients with symptomatic heart failure have been due to heart failure or [cardiovascular] “Deaths caused by heart failure and 25% of hospitalizations are being treated. Kerendia can now help patients reduce these risks,” said Alanna Morris-Simon, senior medical director of senior medical affairs at Bayer in a prepared statement.
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