FDA approved Repatha (evolocumab) for Cardiovascular Risk Reduction in AdultsFDA approved Repatha to lower heart risks and bad cholesterol

Repatha is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor. It binds to PCSK9 and inhibits its binding to the LDL receptor, thereby increasing the number of LDL receptors available to clear LDL from the blood.

Repatha is indicated to reduce the risk of major adverse cardiovascular events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. It is also indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, in adults and pediatric patients aged 10 years and older with HeFH, and in adults and pediatric patients aged 10 years and older with HoFH.

For adults at increased risk for CV events or with hypercholesterolemia, and for adults and pediatric patients aged 10 years and older with HeFH, the recommended dosage is either 140 mg every 2 weeks or 420 mg once monthly administered subcutaneously. For HoFH, the initial recommended dosage is 420 mg once monthly, which can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks. Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks. Administer after apheresis. Assess LDL-C when clinically appropriate; effect may be measured as early as 4 weeks after initiation. For missed doses: within 7 days, administer and resume original schedule; more than 7 days, for every 2-week dose wait until next scheduled dose, for once-monthly dose administer and start new schedule.

Trial data not available in label.

Not reported in label.

Repatha is a PCSK9 inhibitor indicated for cardiovascular risk reduction and LDL-C lowering in patients with hypercholesterolemia, HeFH, or HoFH, including pediatric patients aged 10 years and older. It is used as an adjunct to diet and exercise.