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

-

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