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efgartigimod IV
Efgartigimod IV is a monoclonal antibody that targets and depletes neonatal Fc receptor (FcRn), thereby reducing the levels of immunoglobulin G (IgG) in the body.
Efgartigimod IV is a monoclonal antibody that targets and depletes neonatal Fc receptor (FcRn), thereby reducing the levels of immunoglobulin G (IgG) in the body. Used for Generalized myasthenia gravis.
At a glance
| Generic name | efgartigimod IV |
|---|---|
| Sponsor | argenx |
| Drug class | Monoclonal antibody |
| Target | FcRn |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By binding to FcRn, efgartigimod IV prevents the recycling of IgG back into the circulation, leading to a decrease in IgG levels. This mechanism is thought to be beneficial in treating autoimmune diseases, such as myasthenia gravis, by reducing the levels of pathogenic antibodies.
Approved indications
- Generalized myasthenia gravis
Common side effects
- Infusion-related reactions
- Headache
- Nausea
Key clinical trials
- Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis (PHASE3)
- A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia (PHASE3)
- A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP) (PHASE2, PHASE3)
- ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
- Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis (PHASE2, PHASE3)
- A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
- ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod (PHASE2)
- Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis (PHASE2, PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |