Cardiovascular disease (CVD) is the most common cause of death in the United States and approximately one third of American adults have CVD. Low density lipoprotein cholesterol (LDL) is a major modifiable risk factor for myocardial infarction, stroke, and death from cardiovascular disease. The use of statins to decrease LDL has contributed to the marked decline in death from CVD since 1950, but some patients are not able to tolerate statins and others have inadequate reductions in LDL. In June 2015, the FDA advisory panel voted to recommend approval of two human monoclonal antibodies that target proprotein convertase subtilisin/kexin type 9 (PCSK9) in the blood and markedly reduce LDL cholesterol levels.
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Below you will find the final documents from the assessment review process:
2019 Evidence Update: ICER published this Final New Evidence Update for alirocumab (Praluent®, Regeneron/Sanofi), an injectable PCSK9 inhibitor used for the treatment of high cholesterol in certain patient populations. This New Evidence Update is based on further analysis of results from the ODYSSEY Outcomes trial, which have now undergone peer review and were published in the New England Journal of Medicine on November 7, 2018.