FDA Approves Expanded Label for Praluent

   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 [e-mail]

(END) Dow Jones Newswires

April 26, 2019 20:14 ET (00:14 GMT)

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