FDA Approves Once-Monthly Dosing for Praluent

The new monthly 300mg dose is given as two 150mg injections at two different injection sites
The new monthly 300mg dose is given as two 150mg injections at two different injection sites

Sanofi US and Regeneron announced that the Food and Drug Administration (FDA) has approved a new supplemental Biologics License Application (sBLA) for a once-monthly 300mg dose of Praluent (alirocumab) injection for the treatment of adults with high low-density lipoprotein (LDL) cholesterol.

Praluent, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, is currently indicated as adjunct to diet and maximally tolerated statin therapy, in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease requiring additional lowering of LDL-C. 

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The new monthly 300mg dose is given as two 150mg injections at two different injection sites. The recommended initial dose is now 75mg once every 2 weeks or 300mg once every 4 weeks for patients who prefer less frequent dosing. The FDA approval was supported by data from the Phase 3 ODYSSEY CHOICE I study that examined Praluent 300mg every 4 weeks vs. placebo in patients with hypercholesterolemia who were also taking statin therapy. 

Praluent is available as a 1mL single-dose prefilled pen or syringe in 1- and 2-count cartons. Each pen delivers 150mg of the drug within 20 seconds. 

For more information call (800) 633-1610 or visit Praluent.com.