Regeneron Pharmaceuticals, Inc. and Sanofi has announced that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDAapproved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors.
Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol.
“Despite significant progress over the last decades, high cholesterol remains a leading concern in the U.S. and globally,” said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. “Praluent demonstrates the power of the Sanofi and Regeneron alliance to deliver a first-in-class therapy in the U.S. for patients in need.
View the full release (PDF) here.