JOURNAL ARTICLE

FDA Approves Extended Indication for Evkeeza.

  • Published In: Formulary Watch, 2025. P. 1 1 of 3

  • Database: Business Source Ultimate 2 of 3

  • Authored By: Lutton, Logan 3 of 3

Abstract

The article discusses the extended FDA approval of Evkeeza (evinacumab-dgnb) for the treatment of homozygous familial hypercholesterolemia (HoFH) in patients as young as 1 year old. Initially approved in 2021 for older patients, the drug is an ANGPTL3 antibody inhibitor that helps lower dangerously high levels of low-density lipoprotein cholesterol (LDL-C) associated with HoFH, a severe genetic disorder affecting approximately 1,300 individuals in the U.S. The approval was based on a trial involving six children, which demonstrated a significant reduction in LDL-C levels. The article also highlights the importance of early diagnosis and treatment to prevent serious health complications associated with HoFH. [Extracted from the article]

Additional Information

  • Source:Formulary Watch. 2025/09, p1
  • Document Type:Article
  • Subject Area:Politics and Government
  • Publication Date:2025
  • ISSN:2767-3359
  • Accession Number:188483639
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