Praluent FDA Approval History
Last updated by Judith Stewart, BPharm on March 11, 2024.
FDA Approved: Yes (First approved July 24, 2015)
Brand name: Praluent
Generic name: alirocumab
Dosage form: Injection
Company: Sanofi
Treatment for: High Cholesterol, High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous, Cardiovascular Risk Reduction
Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody used for the treatment of familial hypercholesterolemia and to reduce the risk of cardiovascular events in people with cardiovascular disease.
- Praluent is incidated:
- to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
- as adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
- as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
- as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.
Development timeline for Praluent
Further information
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