FDA accepts supplemental biologics licence application for Praluent

The US Food and Drug Administration (FDA) has accepted a supplemental biologics licence application (sBLA) for Praluent (alirocumab) injection as a potential treatment to reduce major adverse cardiovascular events.

Supported by Phase III trial data, the sBLA outlines a proposed update to the prescribing information to include the effect of Praluent in reducing the overall risk of major adverse cardiovascular events (MACE).

The ODYSSEY OUTCOMES trial assessed the effect of Praluent in nearly 20,000 patients who had an acute coronary syndrome (ACS), such as heart attack, between one and 12 months before enrolling in the trial.

However, the effect of Praluent on cardiovascular morbidity and mortality, including MACE, is under review and has not yet been fully evaluated by any regulatory authority.

In addition to the sBLA, the FDA recently approved an update to the Praluent prescribing information to include clinical information regarding its use in patients with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol along with diet and maximally-tolerated statin therapy and who are undergoing apheresis treatment.

The recommended dose of Praluent in patients undergoing LDL apheresis is 150 mg once every 2 weeks, which can be administered without regard to timing of apheresis. This update was supported by data from the Phase III ODYSSEY ESCAPE trial.

Praluent inhibits 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 to clear LDL, which lowers LDL-C levels in the blood. It is being developed by Regeneronand Sanofi under a global collaboration agreement.