Regeneron : FDA Approves Evkeeza To Treat Ultra-rare Form Of High Cholesterol In Young Children

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) said that the U.S. Food and Drug Administration has approved Evkeeza (evinacumab-dgnb) to treat children aged 5 to 11 with homozygous familial hypercholesterolemia, an ultra-rare form of high cholesterol.

The approval extends Evkeeza to the age group with homozygous familial hypercholesterolemia (HoFH), an inherited condition characterized by extremely high low-density lipoprotein cholesterol (LDL-C).

The company announced a 48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in pivotal trial.

HoFH is an ultra-rare inherited condition that affects approximately 1,300 people in the U.S. and is the most severe form of familial hypercholesterolemia (FH). HoFH occurs when two copies of the FH-causing genes are inherited, one from each parent, resulting in dangerously high levels of LDL-C. Those living with HoFH are at risk for premature atherosclerotic disease and cardiac events even in their teenage years. Many patients are not diagnosed or are only diagnosed later in life.

Evkeeza was invented using Regeneron's VelocImmune technology and is a fully human monoclonal antibody that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that inhibits lipoprotein lipase (LPL) and endothelial lipase (EL) and regulates circulating lipids, including LDL-C.

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