PCSK9 Inhibitors – One Big Step Closer to Approval by the FDA

Two new PCSK9 monoclonal antibodies have been given a nod of approval to the Food and Drug Administration (FDA). The FDA Endocrinologic and Metabolic Drugs Advisory Committee reviewed the evidence on the new class of cholesterol-lowering drugs and recommended that the FDA should approve the new class of LDL-lowering drugs.

This is great news, especially for high risk patients and for Familial Hypercholesterolemia (FH) patients who are not at their LDL-C and non-HDL-C goals on optimal therapy. The NLA is excited about this decision by the FDA advisory committee.

The FDA usually follows the advice of its committees, and the final decision is scheduled for this summer.

The two drugs up for approval are (1) alirocumab (Praluent) by Sanofi and Regeneron, and (2) evolocumab (Repatha) by Amgen.