Efgartigimod alfa/hyaluronidase

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Efgartigimod alfa/hyaluronidase
Combination of
Efgartigimod alfa Neonatal Fc receptor blocker
Hyaluronidase Endoglycosidase
Clinical data
Trade names Vyvgart Hytrulo
Other namesARGX-113, Efgartigimod alfa/hyaluronidase-qvfc
License data
Routes of
administration
Subcutaneous
ATC code
  • None
Legal status
Legal status

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]

Contents

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]

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Efgartigimod alfa, sold under the brand name Vyvgart, is a medication used to treat myasthenia gravis. Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication. It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood. The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis. It is also available coformulated with hyaluronidase.

References

  1. 1 2 3 4 fda/cder (20 June 2023). "Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection" (PDF). Retrieved 24 June 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.