FDA Approves Evolocumab for Cardiovascular Events Risk Reduction


After being granted a Priority Review designation, the PCSK9 inhibitor has been approved for risk reduction of heart attack, stroke, and coronary revascularization.

The US Food and Drug Administration (FDA) approved evolocumab (Repatha, Amgen), for the prophylaxis of heart attacks, strokes, and coronary revascularizations in adults with already established cardiovascular disease (CVD).

This approval marks the first time a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor has been granted an indication for the prevention of the previously mentioned conditions. The treatment has been granted Priority Review status in August.

"We are pleased that the FDA made the inclusion of our outcomes data a priority so that patients can benefit from Repatha's ability to reduce life-changing events of heart attacks and strokes," Sean E. Harper, MD, the executive vice president of Research and Development at Amgen, said in a statement. "Despite treatment with current best therapy, many patients are still at high risk for cardiovascular events. Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering."

The FDA made its decision to approve based on data from the FOURIER study, a cardiovascular outcomes trial that included more than 27,000 patients. The data revealed that evolocumab reduced the risk of heart attack by 27% (P <.001), the risk of stroke by 21% (P = .01), and the risk of coronary revascularization by 22% (P <.001).

Data from FOURIER also showed that adding evolocumab to optimized statin therapy resulted in a 15% reduction in the risk of the study’s primary composite endpoint of hospitalization for unstable angina, coronary revascularization, heart attack, stroke, or cardiovascular death (P <.001).

The therapy was also approved to be used in adjunct to diet for the treatment of adults with hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C), either in combination with other therapies such as statins, or as monotherapy.

Evolocumab’s safety profile data was consistent with the previous studies done on the treatment. Common adverse reactions were diabetes mellitus, nasopharyngitis, and upper respiratory tract infection.

Amgen is currently undertaking a program to provide “personalized support services for patients and providers in the US” called RepathaReady, according to a statement. The program includes a card that gives eligible patients a $5 co-pay for the therapy, as well as insurance coverage support and injection training.

"In the U.S., every 40 seconds someone has a heart attack or stroke, and nearly one in three of these patients will have another event, leading to a societal cost that exceeds $600 billion annually. With this approval, it's now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes. We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine," Anthony C. Hooper, the executive vice president of Global Commercial Operations at Amgen, said in a statement.

A press release was made available.

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