Arulmozhi D. Kandasamy
The U.S. Food and Drug Administration and other regulatory bodies recently approved Praluent (alirocumab) and Repatha (evolocumab) for patients with hereditary forms of high cholesterol and those with cardiovascular disease. These drugs belong to a potent new class of injectable LDL-lowering drugs known as PCSK9 inhibitors. Repatha was approved to treat patients with heterozygous familial hypercholesterolemia (HeFH) and patients with the rarer homozygous (HoFH) form of the disease. It was also approved for patients with cardiovascular disease including heart attack or stroke, who require additional cholesterol lowering. The scope of the approval was similar to the approval given to the Regeneron drug, Praluent (alirocumab), which was approved for patients with cardiovascular disease and those with HeFH.