Praluent Approved for Certain Patients with High Cholesterol
July 24, 2015 – The U.S. Food and Drug Administration (FDA) approved Sanofi and Regeneron’s Praluent (alirocumab). This is the first proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor to be approved by FDA. Praluent is indicated for the treatment of high cholesterol among patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein “bad” cholesterol (LDL-C). HeFH is an inherited condition that causes high levels of LDL-C. Based on an estimate by Sanofi and Regeneron, there are approximately 8-10 million patients in the U.S. with HeFH or clinical ASCVD. ASCVD is caused from a build-up of plague in the arteries that can lead to conditions such as heart attack, stroke and chest pain.
Praluent will be used along with diet and maximally tolerated HMG Co-reductase inhibitor (statin) therapy. The initial dose of Praluent is recommended at 75mg once every two weeks by subcutaneous (SC) injection. Dosage forms include 75mg/mL and 150mg/mL pre-filled syringes and pens for self-administration. It should be noted that in clinical trials, Praluent reduced LDL-C by an additional 46% to 58% in patients on statin therapy. Also to note, is the possibility of the FDA expanding approved indications for Praluent after cardiovascular outcomes data are available in 2017. Praluent will be available through a limited network of specialty pharmacies.
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