FDA Approves First PCSK9 Inhibitor
Indication given for heterozygous HF and secondary prevention
The FDA granted approval to alirocumab (Praluent) for heterozygous familial hypercholesterolemia and for patients with clinical atherosclerotic cardiovascular disease, making it the first in the new class of lipid-lowering PCSK9 inhibitors.
The approval was for use in addition to diet and maximally-tolerated statin therapy in adults who require additional LDL cholesterol lowering.
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