Quick answers
- What is Efgartigimod alfa used for?
- The FDA-approved label (Vyvgart, argenx US, May 13, 2026) says: “VYVGART is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG). VYVGART is a neonatal Fc receptor blocker indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Efgartigimod alfa have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Efgartigimod alfa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Efgartigimod alfa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Efgartigimod alfa?
- 1 company lists prescription products of Efgartigimod alfa in the FDA NDC Directory, including argenx US.
What Efgartigimod alfa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VYVGART is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG). VYVGART is a neonatal Fc receptor blocker indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).
— FDA label: Vyvgart, argenx US, effective May 13, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Vyvgart |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- argenx US1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761195 VYVGART | Argenx Bv | December 17, 2021 | 5, latest May 8, 2026 2026: Efficacy · 2025: Efficacy · 2024: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2587723, 2587729 |
|---|---|
| SPL set ID of the quoted label | 8aefc8e3-26d6-4ff6-aab9-a7542927e084 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761195 |
| Active ingredients (FDA) | EFGARTIGIMOD ALFA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vyvgart, argenx US, effective May 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →