Amgen's Repatha gets FDA nod as high cholesterol treatment

The US Food and Drug Administration late on Thursday approved biotech major Amgen’s (Nasdaq: AMGN) Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Amgen’s shares edged up 1.1% in after-hours trading on Wednesday.

Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

Last month the FDA approved Sanofi and Regeneron Pharmaceuticals' Praluent (alirocumab). Repatha, which was approved by the European Commission last month, is expected to be available in the USA next week.