Efgartigimod alfa/hyaluronidase
| Combination of | |
|---|---|
| Efgartigimod alfa | Neonatal Fc receptor blocker |
| Hyaluronidase | Endoglycosidase |
| Clinical data | |
| Trade names | Vyvgart Hytrulo |
| Other names | ARGX-113, Efgartigimod alfa/hyaluronidase-qvfc |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code |
|
| 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]
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
- ^ a b c d https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761304s000lbl.pdf
- ^ "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.
- ^ "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.
External links
- 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
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