PRALUENT (alirocumab), lipid-lowering agent, anti-PCSK9
CARDIOLOGY - New medicinal product
Opinions on drugs -
Posted on
Aug 23 2016
Reason for request
Inclusion
Insufficient clinical benefit in primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia
- PRALUENT has Marketing Authorisation in primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia.
- The efficacy of PRALUENT was evaluated only in the reduction of one biological criteria, LDL-C level. To date, there is no data justifying the efficacy of alirocumab in terms of morbidity and mortality.
- There remain uncertainties as to alirocumab’s adherence and safety, especially on neurocognitive functions, the risk of development of antibodies and liver safety.
Clinical Benefit
Insufficient |
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Therapeutic use
- |
-
Economic analysis
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