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.
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.