Repatha has become the second drug in a new class known as “PCSK9 inhibitors” to be approved by the Food and Drug Administration for the treatment of high cholesterol.
Repatha, whose generic name is evolocumab, is an injection for treatment of high cholesterol in patients who are unable to control their low-density lipoprotein cholesterol (LDL-C) with current treatments.
The Food and Drug Administration (FDA) have approved the drug in combination with a healthy diet and maximally-tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH) or clinical atherosclerotic cardiovascular disease – such as heart attack or strokes – who require additional lowering of LDL-C.
HeFH and HoFH are inherited conditions that cause high levels of LDL-C. A high level of LDL-C in the blood is linked to cardiovascular or heart disease.
According to the Centers for Disease Control and Prevention (CDC), about 735,000 Americans have a heart attack every year. Heart disease is the leading cause of death for both men and women in America and coronary heart disease is the most common type of heart disease, killing more than 370,000 people annually in the US.
The effectiveness and safety of Repatha were evaluated in a number of trials: one 52-week placebo-controlled trial and eight 12-week placebo-controlled trials. Two of these trials specifically enrolled participants with HeFH, while one enrolled participants with HoFH. Compared with a placebo, those taking Repatha had an average reduction in LDL-C of approximately 60%.
Repatha is a monoclonal antibody that inhibits the activity of PCSK9 (Proprotein convertase subtilisin/kexin type 9).
PCSK9 is a protein that plays a critical role in the modulation of plasma LDL-C levels. By promoting the low-density lipoprotein receptor (LDLR) degradation within hepatocytes, PCSK9 reduces the concentration of LDLRs on the hepatocyte surface, resulting in increased LDL-C levels.
Repatha stops PCSK9 from reducing LDLR concentrations, leading to a reduction in LDL-C.
“Repatha provides another treatment option in this new class of drugs for patients with HeFH or with known cardiovascular disease who have not been able to lower their LDL-C enough with statins,” says Dr. John Jenkins, director of the Office of New Drugs, Center for Drug Evaluation and Research, adding:
“Cardiovascular disease is a serious threat to the health of Americans, and the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem.”
“Repatha provides another treatment option in this new class of drugs for patients with HeFH or with known cardiovascular disease who have not been able to lower their LDL-C enough with statins,” says Dr. Jenkins.
A trial evaluating the effect of adding Repatha to statins for reducing cardiovascular risk is currently taking place.Medical News Today“unquestionable” means for lowering cardiovascular risk
Written by Jonathan Vernon