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