Efgartigimod alfa
| Clinical data | |
|---|---|
| Trade names | Vyvgart |
| Other names | ARGX-113, Efgartigimod alfa-fcab |
| License data | |
| Routes of administration | Intravenous |
| Drug class | Neonatal Fc receptor blocker |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| 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.[1][2]
The most common side effects include respiratory tract infections, headache, and urinary tract infections.[2]
Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication.[2] It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood.[2] The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis.[2] It was approved for medical use in the United States in December 2021.[2][3][4]
Medical uses
Efgartigimod alfa is indicated for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.[2]
History
The safety and efficacy of efgartigimod alfa were evaluated in a 26-week clinical study of 167 participants with myasthenia gravis who were randomized to receive either efgartigimod alfa or placebo.[2] The study showed that more participants with myasthenia gravis with antibodies responded to treatment during the first cycle of efgartigimod alfa (68%) compared to those who received placebo (30%) on a measure that assesses the impact of myasthenia gravis on daily function.[2] More participants receiving efgartigimod alfa also demonstrated response on a measure of muscle weakness compared to placebo.[2]
Society and culture
Legal status
The U.S. Food and Drug Administration (FDA) granted the application for efgartigimod alfa fast track and orphan drug designations.[2][5][6][7] The FDA granted the approval of Vyvgart to Argenx BV.[2]
Names
Efgartigimod alfa is the international nonproprietary name (INN).[8]
References
- ^ a b "Vyvgart- efgartigimod alfa injection". DailyMed. Retrieved 24 December 2021.
- ^ a b c d e f g h i j k l m "FDA Approves New Treatment for Myasthenia Gravis". U.S. Food and Drug Administration (FDA) (Press release). 17 December 2021. Retrieved 21 December 2021.
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". Argenx (Press release). 17 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. Retrieved 21 December 2021 – via Business Wire.
- ^ "Efgartigimod alfa Orphan Drug Designations and Approvals". U.S. Food and Drug Administration. 2 January 2019. Retrieved 21 December 2021.
- ^ "Efgartigimod alfa Orphan Drug Designations and Approvals". U.S. Food and Drug Administration. 20 September 2017. Retrieved 21 December 2021.
- ^ "Efgartigimod alfa Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 11 August 2021. Retrieved 21 December 2021.
- ^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78". WHO Drug Information. 31 (3). hdl:10665/330961.
This article incorporates public domain material from the United States Department of Health and Human Services
Further reading
- Howard JF, Bril V, Vu T, Karam C, Peric S, Margania T, et al. (July 2021). "Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial". Lancet Neurol. 20 (7): 526–536. doi:10.1016/S1474-4422(21)00159-9. PMID 34146511. S2CID 235456637.
External links
- "Efgartigimod alfa". Drug Information Portal. U.S. National Library of Medicine.
- 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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