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Praluent approved by NICE for people with raised cholesterol levels who are at significantly high risk of a heart attack or stroke

Sanofi has announced that the National Institute for Health and Care Excellence (NICE) has recommended Praluent® (alirocumab) as a treatment option for people who have raised levels of ‘bad’ cholesterol (low-density lipoprotein cholesterol), or LDL-C, and who are at significantly high risk of a heart attack or stroke.2, 3

Sanofi welcomes NICE’s decision at the Final Appraisal Determination (FAD) phase to recommend alirocumab as a treatment option for certain people with inherited raised cholesterol levels and those at high risk of cardiovascular events.2 Praluent is authorised for use in patients who are unable to reach their low-density lipoprotein (LDL), or ‘bad’ cholesterol treatment goals, despite modifying their diet and taking a maximum tolerated dose of a statin and/or other lipid-lowering therapies.3 These patients include those with: high levels of LDL cholesterol; an inherited form of high cholesterol levels – heterozygous familial hypercholesterolaemia (HeFH); and patients who are statin intolerant, or contraindicated.3 The effect of alirocumab on CV morbidity and mortality has not yet been determined. The product was developed jointly by Sanofi and Regeneron.

“Praluent represents an important innovation in the therapeutic options available to treat people living with raised cholesterol levels. Sanofi is pleased with today’s positive recommendation from NICE as it will allow healthcare professionals to better manage their patients at a significant level of risk of cardiovascular disease.” said Dr Tunde Falode, Director of the Cardiovascular Division at Sanofi. “Importantly, Praluent is the only PCSK9 inhibitor available in two different strengths – 75 mg and 150 mg – providing doctors with the flexibility to meet the needs of their individual patients.”

Alirocumab belongs to the most recent cholesterol-lowering class of treatments called PCSK9 inhibitors. PCSK9 is a protein that plays an important role in managing ‘bad’ cholesterol by regulating the number of receptors for ‘bad’ cholesterol on the liver’s surface. By reducing PCSK9, the treatment increases the availability of receptors for ‘bad’ cholesterol and therefore lowers the levels of ‘bad’ cholesterol in the blood.3

Despite the widespread use of statins and other lipid-lowering therapies to reduce raised cholesterol levels, some people in the UK remain at significant risk of having a cardiovascular event and are unable to lower their cholesterol to levels indicated within national guidelines.4 In the ODYSSEY LONG TERM clinical trial where people with raised cholesterol levels and at high risk of developing a cardiovascular event were treated with alirocumab 150 mg every two weeks, alirocumab was able to reduce ‘bad’ cholesterol by 61% at week 24 versus an increase of 0.8% for the patients on placebo.1 In this trial, patients in both treatment groups were also receiving statins at the maximum tolerated dose.