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Eberhard Blind, Pieter A de Graeff, Illiana Meurs, Frank Holtkamp, Ania Baczynska, Heidi Janssen, The European Medicines Agency's approval of proprotein convertase subtilisin/kexin type 9 inhibitors, European Heart Journal, Volume 42, Issue 18, 7 May 2021, Pages e2–e3, https://doi.org/10.1093/eurheartj/ehv673
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Important information concerning alirocumab and evolocumab
Recently, Shimada and Cannon reviewed in this journal the development of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, a new therapeutic option for the treatment of familial hypercholesterolaemia 1 ; indeed, two new medicines, Repatha (active substance: evolocumab 2 ) and Praluent (active substance: alirocumab 3 ), have now received a marketing authorization in the European Union (17 July 2015 and 23 September 2015, respectively) as first in class PCSK9 inhibitors.
The two products are authorized for the use in adults with the heterozygous familial or the non-familial form of primary hypercholesterolaemia or with mixed dyslipidaemia, either as add-on when treatment with statins (which may also include other lipid-lowering agents) is insufficient or (as monotherapy or combined with other agents) when treatment with statins is not tolerated or is contraindicated; evolocumab, in addition, is also authorized for the use in homozygous familial hypercholesterolaemia (for details, see Refs 2, 3).