Approval of alirocumab for the treatment of hypercholesterolemia

Sanofi's and Regeneron's Praluent® approved in the EU

30-Sep-2015 - France

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

The EC approved Praluent for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [HeFH] and non-familial) or mixed dyslipidemia as an adjunct to diet:

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

alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular (CV) morbidity and mortality has not yet been determined.

The EC marketing authorization is based on data from 10 pivotal Phase 3 ODYSSEY trials, including five placebo-controlled and five ezetimibe-controlled. 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. In the placebo-controlled trials, the average LDL-cholesterol reductions from baseline at week 24 for the Praluent group ranged from 46 to 61 percent. In the ezetimibe-controlled trial with Praluent added to background statins, the average change in LDL-cholesterol from baseline was 51 percent at week 24. In the ezetimibe trials with patients not on statins, the average LDL-cholesterol reduction from baseline in the Praluent group ranged from 45 to 47 percent at week 24. Additionally, significantly more patients achieved an LDL-cholesterol level of less than 70 mg/dL (<1.81 mmol/L) in the Praluent group compared to placebo or ezetimibe at week 12 and week 24.

In eight trials patients initially started on Praluent 75 mg every two weeks, and had their dose up-titrated to 150 mg every two weeks at week 12 if needed to reach protocol-specified LDL-cholesterol targets. Patients who initially started on Praluent 75 mg every two weeks experienced average LDL-cholesterol reductions from baseline ranging from 44.5 percent to 49 percent at week 12. The majority of patients achieved their pre-defined LDL-cholesterol target on the 75 mg dose, and maintained treatment at this dose. In two other trials where patients initially started on Praluent 150 mg every two weeks, the average LDL-cholesterol reduction from baseline was 63 percent at week 12. In ODYSSEY LONG TERM, the largest Phase 3 placebo-controlled trial evaluating Praluent to date, LDL-cholesterol reductions were sustained through 78 weeks.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions

https://www.bionity.com/en/news/154791/approval-of-alirocumab-for-the-treatment-of-hypercholesterolemia.html