Skip to main content

Praluent FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

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

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody indicated:

  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
  • as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Development timeline for Praluent

Apr  1, 2021Approval FDA Approves Praluent (alirocumab) as Add-On Therapy for Patients with Homozygous Familial Hypercholesterolemia
Apr 26, 2019Approval FDA Approves Praluent (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization
Feb 11, 2019Sanofi and Regeneron Offer Praluent (alirocumab) at a New Reduced U.S. List Price
Apr 25, 2017Approval Sanofi and Regeneron Announce FDA Approval of a New Once-Monthly Dosing Option for Praluent (alirocumab) Injection
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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.