Repatha Labeling Updated to Expand MACE Indications

The Food and Drug Administration (FDA) has expanded the approval of Repatha^® (evolocumab) to include use in adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C). 

The updated indication now states that Repatha is approved to reduce the risk of MACE, including cardiovascular (CV) death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization, in adults at increased risk for these events. Previously, it was indicated to reduce the risk of MACE in patients who had been diagnosed with CV disease. 

Evolocumab is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. It is designed to block the binding of PCSK9 to low-density lipoprotein receptors (LDLRs), thereby increasing the number of LDLRs available to clear low-density lipoprotein from the blood. 

The initial approval in adults with established CV disease was based on the double-blind, randomized, placebo-controlled FOURIER trial (ClinicalTrials.gov Identifier: NCT01764633). Findings showed evolocumab statistically significantly reduced the risk for the primary composite endpoint of time to first occurrence of CV death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization compared with placebo (P <.0001). 

“Far too many adults at risk of cardiovascular disease are not achieving their LDL-C goals, despite it being one of the most modifiable risk factors for a heart attack or stroke,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. “This label update highlights the real-world need for additional treatment options for at-risk patients.”

The FDA also updated the prescribing information to approve the use of evolocumab as a monotherapy in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). Prior to the update, it was only approved to be administered as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies. 

Additionally, the label emphasizes the use of evolocumab alongside diet and exercise to manage high cholesterol. 

Repatha is also indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia and in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia. 

This article originally appeared on MPR