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# Regeneron’s Evkeeza Expanded Use in Young Children
- URL: https://www.fdaweb.com/regenerons-evkeeza-expanded-use-in-young-children/
- Published: 2023-03-22T12:00:00.000Z
- Updated: 2026-09-14T18:21:17.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154047

FDA has approved an expanded indication for Regeneron Pharmaceuticals’ Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH). The therapy was originally approved 2/2021 as an adjunct to other lipid-lowering therapies in those aged 12 years and older with HoFH.

The approval was based on trial data showing that adding Evkeeza reduced children’s LDL-C by 48% at week 24 on average, which met the trial’s primary endpoint. “Significant reductions were also observed in other key secondary endpoints including levels of apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol,” the company says.

Evkeeza is described by the company as a monoclonal antibody that binds to and blocks the function of angiopoietin-like 3, a protein that inhibits lipoprotein lipase and endothelial lipase and regulates circulating lipids, including LDL-C.