The FDA has expanded approval of Amgen’s PCSK9 inhibitor Repatha (evolocumab), permitting use in adults at increased risk of major adverse cardiovascular events due to uncontrolled LDL cholesterol, even without a prior cardiovascular disease diagnosis, according to an Aug. 25 news release from the drugmaker.
The update widens the therapy’s role in preventive cardiology, particularly for patients who fail to achieve LDL targets on statins or are statin-intolerant. The label also expands Repatha’s use as monotherapy for homozygous familial hypercholesterolemia and underscores the need for use in conjunction with diet and exercise.
The change addresses a growing population of at-risk patients who remain undertreated, Amgen said. Repatha, first approved in 2015, has been shown in trials to reduce LDL cholesterol by about 60% and is now used by more than 5 million people worldwide, according to the release.
