FDA Approves PCSK9 Inhibitor to Reduce Cholesterol

This is the first PCSK9 inhibitor to receive FDA approval, but questions remain for clinicians and patients.

The FDA has approved alirocumab (Praluent) as an adjunctive therapy to lower LDL cholesterol in patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (e.g., myocardial infarction or stroke) who have not been able to lower their LDL sufficiently on statins.

Alirocumab is the first approved drug that inhibits proprotein convertase subtilisin kexin type 9 (PCSK9). This ultimately helps liver receptors remove LDL from the blood. The injectable drug is intended to be used in concert with diet, exercise, and the maximally tolerated dose of statins.

In five clinical trials of patients with HeFH or cardiovascular disease who were already taking statins, alirocumab was associated with a 36% …

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Kelly Young, Physician's First Watch

FDA Approves PCSK9 Inhibitor to Reduce Cholesterol

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