1 INDICATIONS AND USAGE
1.1 Primary Hyperlipidemia
PRALUENT is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia.
11 DESCRIPTION
Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9).
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.
14 CLINICAL STUDIES
The efficacy of PRALUENT was investigated in five double-blind placebo-controlled trials that enrolled 3499 patients; 36% were patients with heterozygous familial hypercholesterolemia
In the trials that enrolled patients with HeFH, the diagnosis of HeFH was made either by genotyping or clinical criteria (“definite FH” using either the Simon Broome or WHO/Dutch Lipid Network criteria).
Patient Information
- What is PRALUENT?
PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL).