FDA Update: Agency Grants Priority Review to Evinacumab-Dgnb For Pediatric HoFH

The U.S. Food and Drug Administration (FDA) has granted priority review of "the supplemental biologics license application for evinacumab-dgnb as adjunctive treatment for homozygous familial hypercholesterolemia (HoFH) in children aged 5 to 11 years," according to a Regeneron press release.

The agency's target action date is March 30, 2023. Access more information on the company's announcement here.

For more on this clinical topic, access CardioSmart's patient resources and ACC's online course, Familial Hypercholesterolemia: Improving Detection to Accelerate Treatment.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Dyslipidemia, CHD and Pediatrics and Prevention, Homozygous Familial Hypercholesterolemia, Lipid Metabolism, Primary Hyperlipidemia

Keywords: ACC Advocacy, United States Food and Drug Administration, Child, Hyperlipoproteinemia Type II, Hypercholesterolemia, Biological Products


< Back to Listings