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A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

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Trial Profile

A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2025

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At a glance

  • Drugs Evinacumab (Primary)
  • Indications Hyperlipoproteinaemia type II; Hyperlipoproteinaemia type IIa
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 14 Jul 2025 According to Ultragenyx Pharmaceutical media release, Health Canada has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat children aged 6-months and older with homozygous familial hypercholesterolemia (HoFH).
  • 06 Jan 2025 According to Ultragenyx Pharmaceutical media release, company announced that the European Commission (EC) has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged 6 months to 5 years with homozygous familial hypercholesterolemia (HoFH).
  • 18 Dec 2023 According to Ultragenyx Pharmaceutical media release, company announced that the European Commission (EC) has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH).

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