Preclinical discovery and development of evolocumab for the treatment of hypercholesterolemia.
Level 5 - mechanism / opinion, no new human data
Narrative review and expert opinion with no primary human data or systematic synthesis
PubMed 31973581 · doi:10.1080/17460441.2020.1704728
What was done
The authors reviewed the timeline and preclinical-to-clinical development of evolocumab, a monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9) used as an adjunct lipid-lowering therapy for familial hypercholesterolemia and atherosclerotic cardiovascular disease.
What was found
The abstract provides a descriptive overview without numerical outcome metrics. It notes that PCSK9 was identified in 2002, leading to evolocumab's regulatory approval in 2015 for lowering LDL-cholesterol and reducing cardiovascular events, while highlighting ongoing real-world challenges regarding drug affordability, accessibility, and cost-effectiveness.
Why it matters
It summarizes the translational pipeline of PCSK9 inhibition from molecular target discovery to clinical practice, emphasizing the implementation barriers faced by high-cost precision biologic therapies.
Limits
The abstract contains no empirical trial data, effect estimates, or systematic review methodology. It represents a narrative overview and expert opinion.
Cited by
- supports PCSK9 inhibitors lower LDL by targeting a protein that breaks down LDL receptors.