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Approval of Praluent (alirocumab) for the treatment of hypercholesterolemia in the European Union

Sanofi and , announced today that the (EC) has granted marketing authorization for Praluent® (alirocumab) for the treatment of bad cholesterol, known as low-density lipoprotein (LDL) cholesterol, in certain with . 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 hypercholesterolemia [HeFH] and non-familial) 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 effect of Praluent on cardiovascular (CV) morbidity and mortality has not yet been determined.

is a significant health concern in Europe. According to the World Health Organization (WHO), Europe has the greatest prevalence per capita of in the world (54 percent) followed by the WHO Region of Americas (48 percent). High LDL-cholesterol is a major risk factor for cardiovascular disease (CVD), which remains the leading cause of death around the world. Unfortunately, despite treatment with current standard-of-care, including statins and and/or other lipid-lowering therapies, many Europeans continue to have poorly controlled LDL-cholesterol including those with HeFH, high CV risk; and/or those with a history of statin-intolerance. For some of these patients, additional treatment options are needed to more aggressively lower their cholesterol.

“Our clinical program focused on patients with the highest unmet needs, most of whom were on maximally-tolerated statins and/or other lipid-lowering therapies,” said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. “It was very exciting for us to see that the majority of these patients, most of whom continued to have very high LDL-cholesterol despite treatment with other lipid-lowering drugs, were able to achieve their cholesterol-lowering goals within weeks of adding Praluent to their treatment regime.”