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.
About Repatha® (evolocumab)
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.
Important U.S. Safety Information
Indications
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated:
• To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
• As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:
• adults with hypercholesterolemia.
• adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
• adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia.
