Sanofi lands EC approval for its cholesterol-busting Praluent

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The European Commission (EC) has approved Praluent (alirocumab) – a cholesterol-busing treatment from Sanofi and Regeneron Pharmaceuticals, Inc.

The approval makes Praluent the first EC approved PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor for the treatment of bad cholesterol, known as low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia. The treatment comes in two starting self-administer doses as a single 1-milliter (mL) injection (75 mg and 150 mg) once every two weeks, offering two levels of efficacy.

Praluent has been approved for treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet either 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.

It can also be taken 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.

According to the World Health Organization (WHO), Europe has the greatest prevalence per capita of high cholesterol in the world (54 per cent) followed by the WHO Region of Americas (48 per cent). 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.