REPATHA (evolocumab), anti-PCSK9
CARDIOLOGY - New medicinal product
Opinions on drugs - Posted on Dec 07 2017
Reason for request
Minor clinical added value in uncontrolled homozygous familial hypercholesterolaemia
Insufficient clinical benefit in heterozygous familial or non-familial hypercholesterolaemia and primary mixed dyslipidaemia
- REPATHA has Marketing Authorisation in primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and homozygous familial hypercholesterolaemia in combination with statins (except in case of intolerance or contraindication to statins).
- In homozygous familial hypercholesterolaemia, the efficacy of REPATHA, in combination with other lipid-lowering agents, has been demonstrated only in terms of reduction of biological parameters (LDL-C). The efficacy in terms of morbidity and mortality has not been demonstrated.
- In primary hypercholesterolaemia and mixed dyslipidaemia, there are therapeutic alternatives that have demonstrated their efficacy in terms of morbidity and mortality. In this context, the efficacy of evolocumab was demonstrated only in one biological criteria (reduction of LDL-C levels) in studies in which the majority of patients were not treated at the maximum tolerated dose of statins and for whom the level of cardiovascular risk was not systematically considered.
- There remain uncertainties as to its adherence and its safety, especially on neurocognitive functions, the risk of diabetes and liver safety.
Clinical Added Value
Évaluation des médicaments
HAS opinions and decisions