FDA approve new drug to treat high cholesterol

FDA approve new drug to treat high cholesterol

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. 

High levels of LDL cholesterol can raise the risk for cardiovascular disease.

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%.

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