The FDA ( Food and Drug Administration ) has approved Praluent ( Alirocumab ) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 ( PCSK9 ) inhibitors.
Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia ( HeFH ) or patients with clinical atherosclerotic cardiovascular disease such as myocardial infarctions or strokes, who require additional lowering of LDL cholesterol.
Heterozygous familial hypercholesterolemia is an inherited condition that causes high levels of low-density lipoprotein ( LDL ) cholesterol.
A high level of LDL cholesterol in the blood is linked to cardiovascular disease.
Alirocumab is an antibody that targets a specific protein, called PCSK9, which works by reducing 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 Praluent were evaluated in five placebo-controlled trials, involving 2,476 participants exposed to Praluent.
All participants had heterozygous familial hypercholesterolemia or were otherwise at high risk for myocardial infarction or stroke, and were taking maximally tolerated doses of a statin, with or without other lipid-modifying therapies.
Participants taking Praluent had an average reduction in LDL cholesterol ranging from 36 to 59%, compared to placebo.
Multiple clinical trials have demonstrated that statins lower the risk of having a myocardial infarction or stroke. A trial evaluating the effect of adding Alirocumab to statins on reducing cardiovascular risk is ongoing.
The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given, nasopharyngitis, and flu. Allergic reactions, such as hypersensitivity vasculitis ( a skin rash usually appearing as purple-colored spots on the skin associated with inflammation of small blood vessels ) and hypersensitivity reactions requiring hospitalization, have been reported with the use of Praluent.
Patients should stop using Praluent and get medical help if they experience symptoms of a serious allergic reaction. ( Xagena )
Source: FDA, 2015