FDA Expands Use of Repatha (evolocumab)

Aug. 25, 2025 — Amgen has announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as "bad cholesterol." The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease.

"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. Repatha is an effective therapy for reducing LDL-C, particularly in patients whose disease remains uncontrolled with statins or who cannot tolerate them."

In addition to expanding Repatha's label to include adults at increased risk of MACE, the FDA also:

• expanded the use of Repatha alone (monotherapy) to include patients with a rare, genetic form of high cholesterol known as homozygous familial hypercholesterolemia (HoFH); and
• emphasized that Repatha should be used alongside diet and exercise for managing high cholesterol.

Repatha was first approved in 2015 and has been used by more than 5 million people worldwide.

Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels. The clinical benefits and safety of Repatha have been studied for 15 years in 50 clinical trials with over 57,000 patients.

Repatha is approved in more than 74 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.