FDA approves Amgen’s Repatha injection to treat certain patients with high cholesterol

Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove LDL-C or bad cholesterol from the blood.

The drug 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.

Amgen Research and Development executive vice president Sean Harper said: "We are excited about today’s approval of Repatha in the US as patients and physicians will now have a new treatment option to lower LDL cholesterol.

"Data from key clinical studies have shown that Repatha significantly reduces LDL cholesterol in patients who have not been able to lower their LDL cholesterol through diet and statins alone.

"At Amgen, we are committed to improving the lives of patients and are inspired by the potential for Repatha to aid in the global fight against one of the major risk factors for cardiovascular disease."

Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood and in the US, there are about 11 million people with ASCVD and/or familial hypercholesterolemia (FH), who have uncontrolled levels of LDL-C over 70mg/dL, despite treatment with statins or other cholesterol-lowering therapies.

The efficacy and safety of Repatha were evaluated in one 52-week placebo-controlled trial and eight 12-week placebo-controlled trials in participants with primary hyperlipidemia, including two that specifically enrolled participants with HeFH and one that enrolled participants with HoFH.

The company noted that participants taking Repatha had an average reduction in LDL cholesterol of about 60%, compared to placebo.