Regeneron: FDA Expands Evkeeza Approval to Children as Young as 1
By Colin Kellaher
Regeneron Pharmaceuticals said the U.S. Food and Drug Administration has expanded approval of its Evkeeza cholesterol drug to cover children as young as 1 year old who have an ultra-rare form of high cholesterol.
Regeneron on Friday said the expanded approval covers Evkeeza as an adjunct to diet and exercise and other lipid-lowering therapies for children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia, a genetic condition that causes extremely high LDL, or bad, cholesterol.
The Tarrytown, N.Y., biotechnology company initially won FDA approval of Evkeeza for people ages 12 and up in 2021, and the agency subsequently approved the drug for children ages 5 to 11 in 2023.
Regeneron, which is responsible for the development and distribution of Evkeeza in the U.S. and is collaborating with Ultragenyx to develop, commercialize and distribute the drug outside of the U.S., reported $41 million in U.S. Evkeeza product sales in the second quarter of 2025.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 26, 2025 07:45 ET (11:45 GMT)
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