Praluent Approved in Europe to Treat Hypercholesterolemia

September 28, 2015—Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has granted marketing authorization for Praluent (alirocumab) for the treatment of low-density lipoprotein (LDL) cholesterol in certain adult patients with hypercholesterolemia. Praluent is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor that is available in two starting doses as a single 1-mL injection of 75 mg or 150 mg once every 2 weeks, offering two levels of efficacy. Praluent will be available in a single-dose prefilled pen that patients self-administer. 

In the announcement, Michel Farnier, MD, of Point Medical in Dijon, France, commented, “The availability of two different Praluent dosing strengths provides for dosing flexibility. In clinical practice, this will enable physicians to tailor treatment based on an individual patient's LDL-cholesterol-lowering needs. In the phase 3 trials, the majority of patients who started on the lower Praluent 75 mg dose were able to achieve their predefined LDL-cholesterol goals, and maintained treatment at this dose throughout the assessment period.” 

According to the companies, the European Commission approved Praluent for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [HeFH] and nonfamilial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin; or, b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The companies advised that the effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.

The European marketing authorization is based on data from 10 pivotal, phase 3 ODYSSEY trials, including five placebo-controlled and five ezetimibe-controlled trials. The data showed consistent, robust reductions in LDL-cholesterol for Praluent compared to placebo or ezetimibe, when added to current standard-of-care, which included maximally tolerated statins. All trials met their primary efficacy endpoint, demonstrating significantly greater reductions from baseline in LDL-cholesterol at week 24, compared to placebo or ezetimibe. Across the phase 3 trials, all-cause mortality was 0.6% in the Praluent group and 0.9% in the control group, with cardiovascular events being the primary cause of death in the majority of these patients. 

In July, the companies announced that Praluent was approved for use in the United States as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol.