Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year
Regeneron Pharmaceuticals, Inc. announced that the FDA has approved EVKEEZA (evinacumab-dgnb) ANGPTL3 antibody, for children aged 1 to under 5 years with homozygous familial hypercholesterolemia (HoFH). This expands the indication from its previous approval for children aged 5–11 and adolescents and adults aged 12 and older. EVKEEZA is approved as an adjunct to diet, exercise, and other lipid-lowering therapies.
“The approval of EVKEEZA for children as young as 1 year addresses a critical unmet need for those with HoFH, a life-threatening condition causing extremely high LDL-C levels ...
