Regeneron: FDA Extends Evkeeza Approval to Children Ages 5 to 11
March 22 2023 - 07:45AM
Dow Jones News
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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