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Efgartigimod alfa/hyaluronidase

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Efgartigimod alfa/hyaluronidase
Combination of
Efgartigimod alfaNeonatal Fc receptor blocker
HyaluronidaseEndoglycosidase
Clinical data
Trade namesVyvgart Hytrulo
Other namesARGX-113, Efgartigimod alfa/hyaluronidase-qvfc
License data
Routes of
administration
Subcutaneous
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

Efgartigimod alfa/hyaluronidase, sold under the brand name Vyvgart Hytrulo, is a coformulation medication used for the treatment of generalized myasthenia gravis.[1] It contains efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase (human recombinant), an endoglycosidase.[1]

It was approved for medical use in the United States in June 2023.[2][3]

Medical uses

Efgartigimod alfa/hyaluronidase is indicated for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.[1]

References

  1. ^ a b c d "Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase- human recombinant injection, solution". DailyMed. 21 June 2023. Retrieved 29 August 2023.
  2. ^ "Halozyme Announces argenx Receives FDA Approval for Vyvgart Hytrulo With Enhanze for Subcutaneous Use in Generalized Myasthenia Gravis" (Press release). Halozyme Therapeutics. 20 June 2023. Retrieved 24 June 2023 – via PR Newswire.
  3. ^ "Argenx Announces U.S. Food and Drug Administration Approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis". Argenx (Press release). 20 June 2023. Retrieved 24 June 2023.
  • Clinical trial number NCT03669588 for "An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness (ADAPT)" at ClinicalTrials.gov