Prescription medicine
Efgartigimod alfa Brand names: Vyvgart
Efgartigimod alfa (Vyvgart) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the efgartigimod alfa FDA label on DailyMed (effective May 13, 2026, argenx US); the BLA 761195 record on Drugs@FDA; every efgartigimod alfa label on DailyMed.
Highlights of the record
FDA label of May 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVYVGART is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).
Forms and strengths
- 20 mg/ml
Injection.
On the market
- Earliest approval on file
- December 17, 2021 Vyvgart, Argenx Bv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,880 through July 30, 2026
What is efgartigimod alfa used for?
From the label: indications and usageVYVGART 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 pharmacologic class: Neonatal Fc Receptor Blocker.
Source: FDA drug label (VYVGART), argenx US, effective May 13, 2026 (SPL set 8aefc8e3-26d6-4ff6-aab9-a7542927e084), via openFDA; the full label on DailyMed
Is there a generic for efgartigimod alfa (Vyvgart)?
No generic efgartigimod alfa is approved (Drugs@FDA, October 8, 2026).
- 2021 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for efgartigimod alfa?
The FDA Adverse Event Reporting System holds 3,880 reports that list efgartigimod alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 372 are coded as a death and 1,888 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (1,668, against a median of 3 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other neonatal Fc receptor blockers
- the pharmacologic class, with prices and generics
- Efgartigimod alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other