Praluent Approval History
- FDA approved: Yes (First approved July 24th, 2015)
- Brand name: Praluent
- Generic name: alirocumab
- Dosage form: Injection
- Company: Sanofi and Regeneron Pharmaceuticals, Inc.
- Treatment for: High Cholesterol, High Cholesterol, Familial Heterozygous
Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody for the treatment of heterozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.
Praluent use is approved in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
Based on labeling, the recommended starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks, since the majority of patients achieve sufficient LDL-C reduction with this dosage. If the LDL-C response is inadequate, the dosage may be increased to the maximum dosage of 150 mg administered every 2 weeks.
Praluent was evaluated for effectiveness and safety in five placebo-controlled trials, involving 2,476 patients. All patients had HeFH or were otherwise at high risk for heart attack or stroke, and were taking maximally tolerated doses of a statin, with or without other cholesterol-lowering agents. Participants taking Praluent had an average reduction in LDL cholesterol ranging from 36 to 59 percent, compared to placebo. The most common side effects have included nasopharyngitis, injection site reactions, and influenza. Serious allergic reactions were also reported.
Development History and FDA Approval Process for Praluent
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.