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# Amgen sBLA Approved for Cardiovascular Risk Reduction
- URL: https://www.fdaweb.com/amgen-sbla-approved-for-cardiovascular-risk-reduction/
- Published: 2017-12-04T12:00:00.000Z
- Updated: 2026-09-14T23:04:56.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5140255

FDA has approved an Amgen supplemental BLA for Repatha (evolocumab) for preventing heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. Repatha is the first PCSK9 inhibitor to achieve this indication, according to the company. Approval was based on data from a cardiovascular outcomes study (FOURIER) demonstrating that adding Repatha to optimized statin therapy reduced the risk of heart attack by 27%, stroke risk by 21%, and the risk of coronary revascularization by 22%, according to Amgen. The agency also approved Repatha to be used as an adjunct to diet, alone or in combination with other lipid-lowering therapies for treating adults with primary hyperlipidemia to reduce low density lipoprotein cholesterol.