28 September 2015 - Sanofi and Regeneron Pharmaceuticals, Inc. announced today 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."

For more details, go to: http://en.sanofi.com/NasdaQ_OMX/local/press_releases/sanofi_and_regeneron_announce__1954409_28-09-2015!07_00_00.aspx