FDA Approves Evolocumab (Repatha) to Prevent CV Events

Megan Brooks

December 01, 2017

THOUSAND OAKS, CA — After priority review, the US Food and Drug Administration (FDA) has approved a supplemental application for evolocumab (Repatha, Amgen), making it the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor indicated to prevent MI, stroke, and coronary revascularization in adults with established cardiovascular disease (CVD)[1].

The FDA also approved evolocumab as an adjunct to diet, alone or in combination with other lipid-lowering therapies such as statins, for the treatment of adults with primary hyperlipidemia to reduce LDL cholesterol.  

Evolocumab was approved in 2015 for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous and homozygous familial hypercholesterolemia or clinical evidence of atherosclerotic cardiovascular disease who require further LDL-cholesterol lowering.

Approval was based on results of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) outcomes trial. In that study, evolocumab decreased major cardiovascular-events risk, in addition to significantly lowering LDL-cholesterol levels.

The trial, which included more than 27,000 participants with atherosclerotic CVD already receiving statins, showed that patients who received injections of evolocumab at doses of 140 mg every other week or 420 mg monthly had a 15% reduced risk for the composite of MI, stroke, CV death, coronary revascularization, and unstable angina hospitalization at 22 months compared with those receiving matching placebo (P<0.001).

For a key secondary end point—MI, stroke, or CV death—the study showed a 20% risk reduction for the evolocumab group (P<0.001).

"The magnitude of risk reduction in both the primary and key secondary composite end points grew over time, with the robust benefit starting as early as 6 months and accruing through the median 2.2 years of the study," Amgen said in a news release.

The safety profile of evolocumab in the outcomes trial was generally consistent with the safety profile for the 12- and 52-week controlled trials involving patients with primary hyperlipidemia, including heterozygous familial hypercholesterolemia. Common adverse reactions included diabetes mellitus, nasopharyngitis, and upper-respiratory-tract infection.

Evolocumab is approved in more than 50 countries, including Canada, Japan, the US, and in all 28 countries that are members of the European Union.

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