Regeneron Reports FDA Approval Extending Indication Of Evkeeza

(RTTNews) - Regeneron Pharmaceuticals (REGN) announced the FDA has approved Evkeeza ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia.

Evkeeza was approved in 2021 for adults and adolescents aged 12 years and older with HoFH based on a placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo. It was approved for children aged 5 to 11 in 2023.