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Reimbursement reviews of drugs later in the life cycle include a comprehensive assessment of clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations, and impacts on the health systems. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal ...
CDA-AMC
core +17 more sources
Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. [PDF]
ObjectivesThe aim of this study was to compare biweekly and monthly evolocumab with placebo and oral ezetimibe in patients with hypercholesterolemia in a phase III trial.BackgroundEvolocumab, a fully human monoclonal antibody against proprotein ...
Scott M. Wasserman +2 more
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Evolocumab for the treatment of hypercholesterolemia
Expert Opinion on Biological Therapy, 2017Evolocumab is a fully human monoclonal immunoglobulin G2 directed against human proprotein convertase subtilisin/kexin type 9 (PCSK9). It is administered by subcutaneous injection every 2 weeks or once monthly. Area covered: Herein, the authors discuss the rationale for inhibiting PCSK9 and describe the pharmacodynamics, pharmacokinetics and clinical ...
Brian, Tomlinson +4 more
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A safety evaluation of evolocumab
Expert Opinion on Drug Safety, 2017Evolocumab is an injectable, fully human monoclonal antibody and a member of the newest class of low density lipoprotein cholesterol (LDL-C) lowering agents called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. The PCSK9 inhibitors are the most significant advance in lipid therapy since the introduction of the first statin 30 years ...
openaire +2 more sources
Evolocumab: A Review in Hyperlipidemia
American Journal of Cardiovascular Drugs, 2015Evolocumab (Repatha(®)) is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) that is administered subcutaneously at a dosage of 140 mg every 2 weeks or 420 mg once monthly. Across 12-week phase III trials in patients with primary hypercholesterolemia or mixed dyslipidemia, evolocumab was more effective than placebo ...
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