Statement on FDA Approval on Repatha™ (evolocumab)

National Forum

August 27, 2015

The National Forum for Heart Disease & Stroke Prevention is pleased that the U.S. Food and Drug Administration (FDA) approved Repatha™ (evolocumab), the second PCSK9 inhibitor to enter the market this year. This newly available therapy will serve to markedly reduce low density lipoprotein cholesterol (LDL-C), or “bad cholesterol”, among patients whose elevated LDL-C levels place them at elevated risk for heart attacks and strokes. Repatha has been shown in clinical trials to significantly reduce LDL-C, with minimal side effects, among patients with cholesterol levels that are too high despite previous therapies or who have familial hyperlipidemia, an inherited high cholesterol disorder.

Elevated cholesterol levels affect approximately 1 in 2 men and 1 in 3 women during their lifetimes. Uncontrolled high cholesterol increases one’s risk for atherosclerosis, the most common cause of heart attacks and strokes. The Centers for Disease Control and Prevention estimates that at least 200,000 heart attacks could have been prevented if various risk factors, like cholesterol, were properly managed.

The FDA specifically approved Repatha for an important set of patients: Adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), and clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol. Based on the data published so far, PCSK9 inhibitors are a major advancement in heart disease and stroke prevention. In consideration of this fact, the National Forum eagerly awaits the results of Repatha’s long-term clinical trials as they may confirm reduction in heart disease and strokes in patients similar to those covered by the FDA’s approval. Therefore, this therapy has the potential to help our member organizations further reduce the number of heart attacks and strokes within the U.S. However, the National Forum recognizes that no single therapy can do this job alone. Patients must adopt heart healthy behaviors and, if indicated, use medication as prescribed by their health providers. Moreover, they must be able to afford it throughout their lifetimes.

Unfortunately, too many Americans are unaware that their high cholesterol levels increase their risk for heart attacks and strokes, which means too many people could die prematurely. That is why the National Forum is calling on our member organizations to elevate the dialogue on the "C" of the ABCS (appropriate Aspirin use, Blood pressure control, Cholesterol management and Smoking cessation) of heart disease and stroke prevention as we move into September, which is Cholesterol Awareness Month. We must all encourage patients and practitioners to highlight cholesterol management this September and in the months thereafter. We must consistently prioritize this element of the ABCS if PCSK9 inhibitors are to deliver on their promise.  


The National Forum for Heart Disease & Stroke Prevention is where the most dynamic and diverse organizations collaborate to prevent cardiovascular disease. The National Forum provides a forum and outlet for organizations to amplify their voices. Members include more than 80 U.S. and international organizations representing public, private, health care, advocacy, academic, policy, and community sectors. Our mission is to lead and encourage collaborative action that improves heart-health at the community, state and national levels.

For more information, contact:
Erica Ballard

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