FDA Expands Evolocumab Approval for Broad Cardiovascular Protection

Evolocumab (Repatha) is now approved for adults at increased risk of major adverse cardiovascular events, regardless of prior CVD history, marking a broader indication a decade after its initial launch.

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.