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Praluent Approval History

FDA Approved: Yes (First approved July 24, 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 indicated:

  • 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.
  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

Development History and FDA Approval Process for Praluent

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

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