Expanded Indication for PCSK9 Inhibitors

The FDA has approved changes to the wording of the cardiovascular risk reduction indications for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors evolocumab (Repatha) and alirocumab (Praluent). Both drugs are now approved to reduce the risk of major adverse cardiovascular events (MACE) in adults at increased risk for these events; they were previously approved to reduce the risk of MACE only in patients with established cardiovascular disease (CVD).