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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.

On June 3, 2015, the anticipated final results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) was published online in the New England Journal of Medicine (NEJM 2015;372:2387-97).

Emphasizes the Importance of LDL-Cholesterol Monitoring, LDL Goal Attainment and Shared Decision Making Between Patients and Provider