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# FDA OKs Sanofi/Regeneron sBLA for Once-monthly Praluent
- URL: https://www.fdaweb.com/fda-oks-sanofi-regeneron-sbla-for-once-monthly-praluent/
- Published: 2017-04-25T12:00:00.000Z
- Updated: 2026-09-14T22:19:31.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138538

FDA has approved a Sanofi and Regeneron Pharmaceuticals supplemental BLA for a once-monthly, 300 mg dose of Praluent (alirocumab) injection for treating adults with high low-density lipoprotein (LDL) cholesterol. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for treating adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.

  
Approval was based on data from the Phase 3 ODYSSEY CHOICE I study, which evaluated Praluent 300 mg every four weeks compared to placebo in patients with hypercholesterolemia who were also taking concomitant statin. The therapy works by inhibiting the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL cholesterol levels in the blood, according to the company.