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Vyvgart (EFGARTIGIMOD ALFA)
Vyvgart works by binding to the p51 subunit of the FcRn receptor, preventing it from recycling antibodies back into the bloodstream.
Vyvgart (Efgartigimod alfa) is a small molecule drug developed by ARGENX BV, targeting the IgG receptor FcRn large subunit p51. It works as a neonatal Fc receptor blocker, approved by the FDA in 2021 for the treatment of immune thrombocytopenia and myasthenia gravis. Vyvgart has a half-life of 80 to 120 hours and is currently patented. It is used to reduce the levels of certain antibodies in the body, which can cause these conditions. Key safety considerations include its potential impact on the immune system.
At a glance
| Generic name | EFGARTIGIMOD ALFA |
|---|---|
| Sponsor | Argenx Bv |
| Drug class | Endoglycosidase [EPC] |
| Target | IgG receptor FcRn large subunit p51 |
| Modality | Recombinant protein |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 2500 |
Mechanism of action
Efgartigimod alfa-fcab is human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
Approved indications
- Immune thrombocytopenia
- Myasthenia gravis
Common side effects
- Respiratory tract infection
- Headache
- Urinary tract infection
- Paraesthesia
- Myalgia
- Antibody formation
- Neutralizing antibodies
- Fatigue
Key clinical trials
- A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP). (PHASE3)
- Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis (PHASE3)
- Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome (PHASE2)
- Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (PHASE2)
- A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
- A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
- A Study of Efgartigimod in Patients With IgG4-Related Disease (PHASE2)
- Efgartigimod for the Treatment of Acute Optic Neuritis (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Vyvgart CI brief — competitive landscape report
- Vyvgart updates RSS · CI watch RSS
- Argenx Bv portfolio CI