Bayer Gets Speedy FDA Review of Kerendia in Heart Failure

Dow Jones

Mar 17, 2025

By Colin Kellaher

Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.

Bayer on Monday said the application covers Kerendia for the treatment of adults with heart failure with a left ventricular ejection fraction, or LVEF, of at least 40%, also known as mildly reduced or preserved LVEF.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

German drugs-to-crops giant Bayer said about 6.7 million adults in the U.S. live with heart failure, with roughly 55% having mildly reduced or preserved LVEF.

The FDA approved Kerendia in 2021 to improve cardiovascular outcomes for patients with type 2 diabetes and chronic kidney disease. The drug generated sales of around $500 million last year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 17, 2025 06:36 ET (10:36 GMT)

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