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The FDA Approves Regeneron Pharmaceuticals' Evkeeza (Evinacumab-dgnb) 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

Author: Benzinga Newsdesk | September 26, 2025 07:03am
  • FDA approval extends the indication of Evkeeza to treat younger patients with homozygous hypercholesterolemia (HoFH)
  • HoFH is an inherited condition characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C)
  • Initial Evkeeza approval based on placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population

Posted In: REGN


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