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Efgartigimod
Efgartigimod alfa binds to FcRn, reducing circulating IgG, while hyaluronidase increases subcutaneous permeability.
At a glance
| Generic name | Efgartigimod |
|---|---|
| Also known as | efgartigimod alfa, efgartigimod alfa fcab, VYVGART, ARGX-113, Vyvgart |
| Sponsor | M. Peter Marinkovich |
| Drug class | Endoglycosidase [EPC] |
| Target | FcRn |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| Annual revenue | 2500 |
Mechanism of action
VYVGART HYTRULO combines efgartigimod alfa and hyaluronidase. Efgartigimod alfa binds to the neonatal Fc receptor (FcRn), which leads to a reduction in circulating IgG levels. Hyaluronidase temporarily increases the permeability of subcutaneous tissue by breaking down hyaluronan, enhancing drug absorption.
Approved indications
- Immune thrombocytopenia
- Myasthenia gravis
Common side effects
- respiratory tract infection
- headache
- urinary tract infection
- paraesthesia
- myalgia
Key clinical trials
- Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (PHASE2)
- A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome (PHASE3)
- A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP). (PHASE3)
- A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease (PHASE3)
- A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease. (PHASE3)
- Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis (PHASE3)
- Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Efgartigimod CI brief — competitive landscape report
- Efgartigimod updates RSS · CI watch RSS
- M. Peter Marinkovich portfolio CI