FDA Broadens Approval of Amgen’s Repatha to Include Adults at Increased Risk for Major Cardiovascular Events

The approved use of Amgen’s Repatha (evolocumab) has been extended by the U.S. Food and Drug Administration (FDA) to people who are more susceptible to major adverse cardiovascular events (MACE) as a result of uncontrolled low-density lipoprotein cholesterol (LDL-C), also referred to as “bad cholesterol.” This ruling makes the preventative treatment available to a larger community by eliminating the earlier condition that a patient has a prior diagnosis of cardiovascular disease.

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Repatha’s expanded indication is intended to lower the risk of MACE, which encompasses coronary revascularization, myocardial infarction (heart attack), stroke, unstable angina necessitating hospitalization, and cardiovascular death. For a greater number of at-risk patients who have not been able to control their elevated LDL-C with other lipid-lowering treatments alone, this approval represents a major advancement in the prevention of cardiovascular events.

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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,

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.

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Murdo Gordon

Repatha’s expanded indication is intended to lower the risk of MACE, which encompasses coronary revascularization, myocardial infarction (heart attack), stroke, unstable angina necessitating hospitalization, and cardiovascular death. For a greater number of at-risk patients who have not been able to control their elevated LDL-C with other lipid-lowering treatments alone, this approval represents a major advancement in the prevention of cardiovascular events.



Repatha® (evolocumab)

A human monoclonal antibody called Repatha prevents proprotein convertase subtilisin/kexin type 9 (PCSK9) from working. By attaching itself to PCSK9, Repatha stops circulating PCSK9 from attaching to the low-density lipoprotein (LDL) receptor (LDLR). This stops PCSK9 from degrading LDLR and allows LDLR to return to the liver cell surface. Repatha lowers LDL-C levels by increasing the amount of LDLRs available to remove LDL from the blood by blocking PCSK9’s binding to LDLR. For 15 years, 50 clinical trials involving more than 57,000 patients have examined the safety and therapeutic advantages of Repatha.


Information: Amgen

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Ajmal Aseem

Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.

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