FDA approves Praluent, first PCSK9 inhibitor

SILVER SPRING, Md. — The Food and Drug administration announced Friday that it had approved Praluent (alirocumab), a cholesterol-lowering injection. Praluent is the first approval in a new drug class — proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

Praluent, when used in conjunction with statin therapy can help patients lower their LDL cholesterol. The drug works by targeting PCSK9, a protein that prevents liver receptors from removing LDL from the bloodstream. Praluent prevents PCSK9 from working and allows the body to remove more LDL cholesterol. 

“Praluent provides another treatment option for patients with HeFH or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins,” said John Jenkins, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. “The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease.”