FDA

Repatha now indicated for adults at increased risk of CV events due to uncontrolled LDL-C

August 28, 2025

FDA expanded the approved use of Repatha (evolocumab), a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled LDL-C. The update removes a prior requirement for a patient to have been diagnosed with CV disease.

The agency also expanded the use of Repatha monotherapy to include patients with homozygous familial hypercholesterolemia (HoFH). Previously, it had only been approved for use as an adjunct to other LDL-C lowering therapies.

Recommended dose

The recommended dosage of Repatha for patients at increased risk for CV events or with hypercholesterolemia is either 140 mg SC every 2 weeks or 420 mg SC once monthly.

Sources:

Repatha (evolocumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125522s045lbl.pdf Revised August 2025. Accessed August 27, 2025.

Repatha® now indicated for adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C. [News release]. 2025. https://www.amgen.com/newsroom/press-releases/2025/08/repatha-now-indicated-for-adults-at-increased-risk-for-major-adverse-cardiovascular-events-due-to-uncontrolled-ldl-c