The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Praluent (alirocumab; Sanofi and Regeneron) regarding its effect on reducing the risk of major adverse cardiovascular events (MACE).
Praluent, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, is currently approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease requiring additional lowering of low-density lipoprotein cholesterol (LDL-C).
The sBLA is supported by data from the Phase 3 ODYSSEY OUTCOMES trial which included 18,924 patients who had experienced an acute coronary syndrome (ACS) in the previous 12 months. Results showed that the overall risk of MACE was reduced by 15% in patients who received Praluent with maximally-tolerated statins compared with those who remained on statins alone (hazard ratio [HR] 0.85, CI: 0.78-0.93, P=.0003). In a pre-specified analysis, Praluent reduced the risk of MACE by 24% (HR 0.76, CI: 0.65-0.87) in patients with baseline LDL-C levels ≥100mg/dL; findings from a post-hoc analysis of this group showed that Praluent reduced the risk of all-cause mortality by 29% (HR 0.71, CI: 0.56-0.90).
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 28, 2019 to decide on the sBLA.
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