Regeneron: FDA Extends Evkeeza Approval to Children Ages 5 to 11

By Colin Kellaher

Regeneron Pharmaceuticals Inc. on Wednesday said the U.S. Food and Drug Administration extended the approval of its Evkeeza cholesterol drug to cover young children with an ultra-rare form of high cholesterol.

The Tarrytown, N.Y., biotechnology company said the FDA approved Evkeeza as an adjunct to other lipid-lowering therapies for children ages 5 to 11 with homozygous familial hypercholesterolemia, making it the first angiopoietin-like 3 inhibitor treatment indicated for children as young as 5 to control dangerously high levels of low-density lipoprotein cholesterol caused by the disease.

The FDA first approved Evkeeza as an adjunct to other lipid-lowering therapies in patients ages 12 and up in February 2021. Regeneron reported U.S. sales of $48 million for the drug last year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 22, 2023 07:30 ET (11:30 GMT)

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