FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C

The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia

Amgen announced that the U.S. Food and Drug Administration (FDA) has expanded the approved use of Repatha (evolocumab) to include adults at risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C). The updated label removes the previous requirement that patients must have a prior cardiovascular disease diagnosis.

"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."

The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic form of high cholesterol, and emphasized its use alongside diet and exercise to manage high cholesterol.