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 |
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| 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 and chronic inflammatory demyelinating polyneuropathy.[1] It contains efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase (human recombinant), an endoglycosidase.[1]
Efgartigimod alfa/hyaluronidase may increase the risk of infection, including urinary tract infection and respiratory tract infections.[2] In clinical trials, hypersensitivity reactions, including rash, angioedema (swelling), dyspnea (shortness of breath), and urticaria (itchy welts) were observed in people treated with efgartigimod alfa.[2] The most common adverse reactions (≥ 10%) of people with myasthenia gravis treated with efgartigimod alfa were respiratory tract infections, headache, and urinary tract infection.[2]
It was approved for medical use in the United States in June 2023.[3][4]
Medical uses[edit]
Efgartigimod alfa/hyaluronidase is indicated for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.[1]
In June 2024, the US Food and Drug Administration (FDA) expanded the indication for the combination to include the treatment of chronic inflammatory demyelinating polyneuropathy in adults.[2]
History[edit]
The effectiveness of the combination for the treatment of adults with chronic inflammatory demyelinating polyneuropathy was established in a two stage, multicenter study (Study 3; NCT04281472).[2] Study 3 included an open-label period (stage A) to identify people who had evidence of improvement with the use of Vyvgart Hytrulo, who then entered a randomized, double-blind, placebo-controlled, withdrawal period (stage B).[2]
References[edit]
- ^ a b c d "Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase- human recombinant injection, solution". DailyMed. 21 June 2023. Retrieved 29 August 2023.
- ^ a b c d e f This article incorporates text from this source, which is in the public domain.
- ^ "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[edit]
- 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
- Clinical trial number NCT04281472 for "A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) (ADHERE)" at ClinicalTrials.gov
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