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efgartigimod administration
Efgartigimod is a monoclonal antibody that targets and depletes neonatal Fc receptor (FcRn) to reduce immunoglobulin G (IgG) levels.
Efgartigimod is a monoclonal antibody that targets and depletes neonatal Fc receptor (FcRn) to reduce immunoglobulin G (IgG) levels. Used for Generalized Myasthenia Gravis.
At a glance
| Generic name | efgartigimod administration |
|---|---|
| Also known as | Vyvgart |
| Sponsor | Clinique Neuro-Outaouais |
| Drug class | Monoclonal antibody |
| Target | FcRn |
| Modality | Small molecule |
| Therapeutic area | Autoimmune diseases |
| Phase | Phase 3 |
Mechanism of action
By binding to FcRn, efgartigimod prevents the recycling of IgG back to the circulation, leading to a decrease in IgG levels. This mechanism is thought to be beneficial in treating autoimmune diseases.
Approved indications
- Generalized Myasthenia Gravis
Common side effects
- Injection site reactions
- Headache
- Fatigue
- Nausea
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)
- Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis (PHASE3)
- Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome (PHASE2)
- A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia (PHASE3)
- Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
- A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP) (PHASE2, PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- efgartigimod administration CI brief — competitive landscape report
- efgartigimod administration updates RSS · CI watch RSS
- Clinique Neuro-Outaouais portfolio CI