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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