Repatha evolocumab regulatory update

The European Commission approved an MAA from Amgen for Repatha evolocumab to treat several groups of patients with high cholesterol. The approval is the first anywhere for a PCSK9 inhibitor.

Repatha is approved for adults with primary hypercholesterolemia -- including heterozygous familial (HeFH) or non-familial hypercholesterolemia -- or mixed dyslipidemia, as an adjunct to diet in combination with a statin or other therapies in patients unable to reach LDL-C goals on statins alone; or alone or in combination with other lipid-lowering therapies in patients who cannot take statins. The EC also approved Repatha for patients ages >=12 with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies. ...