FDA Approves Praluent for Certain Cases of High Cholesterol
First in a new class of injectable cholesterol-lowering medications.
(HealthDay News) -- Praluent (alirocumab) injection has been approved by the U.S. Food and Drug Administration for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who need additional low-density lipoprotein (LDL) cholesterol reduction.
The drug is sanctioned for patients who do not benefit enough from improved diet and the use of statins. Praluent is the first-approved drug in a new class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. The drug is an antibody that inhibits the PCSK9 protein, which allows more liver receptors to remove LDL from the blood.
Praluent was evaluated in clinical studies involving 2,476 people with high cholesterol who were at risk of heart attack or stroke, and were taking the highest tolerated dose of a statin. Participants given Praluent saw a reduction in LDL cholesterol ranging from 36 to 59%, the FDA said.
The most common side effects of Praluent included itching, swelling, pain, or bruising at the injection site, and flu. Serious allergic reactions, some requiring hospitalization, also were reported.
"Praluent provides another treatment option for patients with heterozygous familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins," John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement.
Praluent is marketed by Bridgewater, N.J.-based Sanofi Aventis and Tarrytown, N.Y.-based Regeneron Pharmaceuticals.