Prescription medicine
Efgartigimod alfa and hyaluronidase Brand names: Vyvgart
Efgartigimod alfa and hyaluronidase (Vyvgart) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the efgartigimod alfa and hyaluronidase FDA label on DailyMed (effective July 15, 2026); every efgartigimod alfa and hyaluronidase label on DailyMed.
Highlights of the record
FDA label of July 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) ( 1 ) chronic inflammatory demyelinating p
Forms and strengths
- 180 mg/ml
- 200 mg/ml
Injection (solution).
On the market
- 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
- 427 through July 30, 2026
What is efgartigimod alfa and hyaluronidase used for?
From the label: indications and usageVYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) ( 1 ) chronic inflammatory demyelinating polyneuropathy (CIDP)
FDA pharmacologic class: Endoglycosidase and Neonatal Fc Receptor Blocker.
Source: FDA drug label (VYVGART Hytrulo), argenx US, effective July 15, 2026 (SPL set 7104d9e5-9910-47f5-9a93-741ac50f43b6), via openFDA; the full label on DailyMed
Is there a generic for efgartigimod alfa and hyaluronidase (Vyvgart)?
No generic efgartigimod alfa and hyaluronidase is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for efgartigimod alfa and hyaluronidase?
The FDA Adverse Event Reporting System holds 427 reports that list efgartigimod alfa and hyaluronidase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 153 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other endoglycosidases
- the pharmacologic class, with prices and generics
- Efgartigimod alfa and hyaluronidase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other