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Praluent Approval History

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

DateArticle
Jul 24, 2015Approval FDA Approves Praluent (alirocumab) to Treat Certain Patients with High Cholesterol
Jun  9, 2015FDA Advisory Committee Recommends Approval of Praluent (Alirocumab) Injection for Patients with Hypercholesterolemia
Mar 15, 2015Sanofi and Regeneron Announce 18-Month Results of ODYSSEY LONG TERM Trial With Praluent (Alirocumab)
Jan 26, 2015Sanofi and Regeneron Announce Praluent (alirocumab) BLA Accepted for Priority Review by FDA
Jan  9, 2015Sanofi and Regeneron Announce Positive Topline Results from Phase 3 Trials Evaluating Monthly Alirocumab

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