Regeneron, Sanofi Announce Approval of Praluent for Treatment of Hypercholesterolemia in EU

Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY today 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 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," said Michel Farnier, M.D., Ph.D., Point Medical, Dijon, France. "In the Phase 3 trials, the majority of patients who started on the lower Praluent 75 mg dose were able to achieve their pre-defined LDL-cholesterol goals, and maintained treatment at this dose throughout the assessment period." The EC approved Praluent for the treatment of adult patients with primary hypercholesterolemia (heterozygous familial See full press release