FDA Approves Expanded Label for Praluent
April 26 2019 - 8:29PM
Dow Jones News
By Maria Armental
Sanofi and Regeneron Pharmaceuticals Inc.'s Praluent has been
approved in the U.S. to prevent heart attack, stroke and unstable
angina requiring hospitalization, the companies said Friday.
Praluent -- initially approved by the Food and Drug
Administration in 2015 as the first of a powerful new class of
cholesterol-lowering medicines -- works by blocking a protein
called PCSK9, which interferes with the body's ability to clear bad
cholesterol.
The companies received an expanded indication to treat patients
with other types of LDL-C, or bad cholesterol.
"Today's FDA approval marks a significant achievement in the
treatment of adults with established cardiovascular disease, who
are among those at greatest risk of death or disability caused by
serious cardiovascular events," Dr. John Reed, Sanofi's global head
of research and development, said in a statement. "Praluent has
already helped many adults lower their LDL-C levels, and this new
indication provides an opportunity to help appropriate patients by
reducing the risk of serious, life-threatening cardiovascular
events, including heart attacks and stroke."
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
April 26, 2019 20:14 ET (00:14 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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