Global InformationEfgartigimod alfa information
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| Trade names | Vyvgart |
| Other names | ARGX-113, efgartigimod alfa-fcab |
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| Routes of administration | Intravenous |
| Drug class | Neonatal Fc receptor blocker |
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| Formula | C2310H3554N602O692S14 |
| Molar mass | 51280.20 g·mol−1 |
Efgartigimod alfa, sold under the brand name Vyvgart, is a medication used to treat myasthenia gravis.[3][4] Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication.[4] It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood.[4] The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis.[4] It is also available coformulated with hyaluronidase.[6]
The most common side effects include respiratory tract infections, headache, urinary tract infections, and paresthesia (numbness, tingling).[4][7]
It was approved for medical use in the United States in December 2021,[4][7][8][9] and in the European Union in August 2022.[5] The US Food and Drug Administration considers it to be a first-in-class medication.[10]
- ^ "Details for: Vyvgart". Health Canada. 6 November 2023. Retrieved 3 March 2024.
- ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]". Health Canada. 22 December 2023. Retrieved 3 January 2024.
- ^ a b "Vyvgart- efgartigimod alfa injection". DailyMed. Archived from the original on 25 December 2021. Retrieved 24 December 2021.
- ^ a b c d e f g "FDA Approves New Treatment for Myasthenia Gravis". U.S. Food and Drug Administration (FDA) (Press release). 17 December 2021. Archived from the original on 20 December 2021. Retrieved 21 December 2021.
This article incorporates text from this source, which is in the public domain.
- ^ a b Cite error: The named reference
Vyvgart EPARwas invoked but never defined (see the help page). - ^ "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.
- ^ a b "Drug Trials Snapshot: Vyvgart". U.S. Food and Drug Administration. 23 May 2023. Retrieved 27 May 2023. This article incorporates text from this source, which is in the public domain.
- ^ "Argenx Announces U.S. Food and Drug Administration (FDA) Approval of Vyvgart (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis" (Press release). Argenx. 17 December 2021. Archived from the original on 20 December 2021. Retrieved 21 December 2021.
- ^ "Argenx Announces U.S. Food and Drug Administration (FDA) Approval of Vyvgart (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis" (Press release). Argenx. 17 December 2021. Archived from the original on 19 December 2021. Retrieved 21 December 2021 – via Business Wire.
- ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
