Paris and Tarrytown, NY – September 12, 2018 – Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. 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). MACE is an umbrella term that includes heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization. The FDA set a Prescription Drug User Fee Act (PDUFA) action date of April 28, 2019.
The sBLA is supported by data from ODYSSEY OUTCOMES, a Phase 3 cardiovascular outcomes trial that assessed the effect of Praluent in 18,924 patients who had an acute coronary syndrome (ACS), such as a heart attack, between 1-12 months (median 2.6 months) before enrolling in the trial. Results of the ODYSSEY OUTCOMES trial were presented at the American College of Cardiology’s 67thAnnual Scientific Session & Expo in March 2018.
The effect of Praluent on cardiovascular morbidity and mortality, including MACE, is currently being reviewed and has not been fully evaluated by any regulatory authority.
Additional Treatment Option for Patients Who Currently Require Apheresis Therapy
In addition, 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 LDL-C (low-density lipoprotein cholesterol) along with diet and maximally-tolerated statin therapy and who are undergoing apheresis treatment. Apheresis is a procedure where LDL-C is removed from the blood, in a process similar to kidney dialysis. The recommended dose of Praluent in patients undergoing LDL apheresis is 150 mg once every 2 weeks. Praluent can be administered without regard to timing of apheresis.
The update is supported by data from the pivotal Phase 3 ODYSSEY ESCAPE trial of 62 patients with HeFH, an inherited form of high cholesterol, whose cholesterol levels required chronic, weekly or bi-weekly apheresis therapy.