FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Amgen Gets FDA Nod for Heart Attack and Stroke Prevention Drug

Dec. 8, 2017
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Repatha, Amgen’s heart attack and stroke prevention drug candidate, secured FDA approval following a priority review.

The drug is the first PCSK9 inhibitor cleared for prevention of strokes, heart attacks and coronary revascularizations in adults with heart disease. The approval follows a study that found it reduced heart attack risk by 27 percent, stroke risk by 21 percent and revascularization risk by 22 percent.

In the approval, the FDA recommended the drug as an adjunct to diet, alone or in combination with other lipid-lowering treatments.

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