Evolocumab (Repatha) to treat certain patients with high cholesterol

Evolocumab (Repatha) to treat certain patients with high cholesterol

Last Updated on September 5, 2015 by Joseph Gut – thasso

September 01, 2015 – The American Food and Drug Administration recently approved Evolocumab (Repatha) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.

Evolocumab (Repatha), the second drug approved in a new class of drugs known as PCSK9  inhibitors is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

Familial hypercholesterolemia (encompassing both HeFH and HoFH) is an inherited condition that causes high levels of LDL cholesterol. A high level of LDL cholesterol in the blood is linked to cardiovascular or heart disease. Heart disease is the number one cause of death for Americans, both men and women. According to the Centers for Disease Control and Prevention, about 610,000 people die of heart disease in the United States every year– that equals one in every four deaths.

“Evolocumab (Repatha) provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” said John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research. “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.”

Evolocumab (Repatha) is an antibody that targets a specific protein, called PCSK9. PCSK9 reduces the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9’s ability to work, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels.

The efficacy and safety of Evolocumab (Repatha) were evaluated in one 52-week placebo-controlled trial and eight 12-week placebo-controlled trials in participants with primary hyperlipidemia, including two that specifically enrolled participants with HeFH and one that enrolled participants with HoFH. In one of the 12-week studies, 329 participants with HeFH, who required additional lowering of LDL cholesterol despite statins with or without other lipid-lowering therapies, were randomized to receive Evolocumab (Repatha) or placebo for 12 weeks. Participants taking Evolocumab (Repatha) had an average reduction in LDL cholesterol of approximately 60 percent, compared to placebo.

The most common side effects of Evolocumab (Repatha) include nasopharyngitis, upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising where the injection is given. Allergic reactions, such as rash and hives, have been reported with the use of Evolocumab (Repatha). Patients should stop using Evolocumab (Repatha) and get medical help if they experience symptoms of a serious allergic reaction.

Multiple clinical trials have demonstrated that statins lower the risk of having a heart attack or stroke. A trial evaluating the effect of adding Evolocumab (Repatha) to statins for reducing cardiovascular risk is still ongoing.

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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