Sanofi: FDA Okays Praluent To Treat Certain Patients With High Cholesterol

(RTTNews) - Sanofi (SNY) and Regeneron Pharmaceuticals Inc (REGN) on Friday said the U.S. 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 heart attacks or strokes, who require additional lowering of LDL cholesterol.

According to the companies, Praluent will be available early next week to U.S. patients, and in two different doses (75 mg and 150 mg).

HeFH is an inherited condition that causes high levels of low-density lipoprotein (LDL) cholesterol. A high level of LDL cholesterol (known as "bad" cholesterol) in the blood is linked to cardiovascular 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.

Praluent 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.

Multiple clinical trials have demonstrated that statins lower the risk of having a heart attack or stroke. A trial evaluating the effect of adding Praluent 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.