European regulators have approved Sanofi/Regeneron’s Praluent to reign in ‘bad’ cholesterol levels in certain patients for whom statins aren’t working or can’t be tolerated.

Specifically, the drug has been green-lighted for treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet, either alongside a statin-based regimen or alone or in combination with other lipid-lowering therapies when statins cannot be taken. 

The move sees Praluent (alirocumab) become the second in the closely-watched PCSK9 inhibitor class of drugs to enter the EU market, following in the footsteps of Amgen’s Repatha (evolocumab), which won clearance back in July for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and for adults and adolescents aged 12 and above with homozygous familial hypercholesterolaemia.

In a bid to differentiate the drug from its rival, Sanofi stressed that Praluent is the only EC-approved PCSK9 inhibitor available in two starting doses, offering two levels of efficacy. “In clinical practice, this will enable physicians to tailor treatment based on an individual patient's LDL-cholesterol-lowering needs,” said Michel Farnier, Point Medical, France.

Despite the widespread availability of statins and other lipid lowerers, high cholesterol remains a huge problem in Europe, where the prevalence (54%) is higher than anywhere else in the world. The companies are hoping that Praluent will help to address current gaps in treatment, after the drug consistently showed its ability to lower cholesterol levels across a stream of clinical trials.

All 10 Phase III clinical studies underpinning its marketing application in Europe met their primary endpoint. In the placebo-controlled trials, the average LDL-cholesterol reductions from baseline at week 24 for the Praluent group ranged from 46% to 61%. In the ezetimibe (Merck & Co’s Zetia)-controlled trial with Praluent added to background statins, the average drop was 51% at week 24, while in ezetimibe trials with patients not on statins, the average reduction was 45%-47%.

The ability of Praluent to reduce major CV events is currently being investigated in the ongoing ODYSSEY OUTCOMES trial, but full results aren’t anticipated until 2017.