Praluent Granted New Indication for Rare Form of High Cholesterol

April 1, 2021 – The U.S. FDA has approved a new indication for Praluent® (alirocumab), manufactured by Regeneron. The drug is now indicated to treat homozygous familial hypercholesterolemia (HoFH), in combination with other HoFH therapies, in adults.

HoFH is a rare genetic condition that affects the body’s ability to remove cholesterol. This causes individuals to develop especially high accumulations of “bad” cholesterol, also known as low-density lipoprotein cholesterol (LDL-C) – as much as four times the normal range. HoFH contributes to early cardiovascular disease and can be fatal before the age of 30 if patients don’t receive aggressive treatment.

In a clinical trial, patients on Praluent saw an average 27% decrease in LDL-C at 12 weeks of treatment compared to an average 9% increase for patients on a placebo. All patients in the study were on LDL-C lowering therapies in addition to either Praluent or the placebo.

Recommended dosing under the new indication is 150mg given via subcutaneous injection once every two weeks. Praluent can be administered at home by the patient or a caregiver once they have been instructed in proper technique by a healthcare professional.

First FDA approved in 2015, Praluent is also indicated to reduce the risk of heart attack, stroke, and unstable angina (a risk factor for heart attacks) requiring hospitalization in adults who have established cardiovascular disease. In addition, Praluent is approved as adjunct to diet, alone, or in combination with other LDL-C lowering therapies in adults who have primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.