VYVGART HYTRULO
BLA 761304 · Biologics License Application (BLA) Prescription
EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC
- Sponsor (Drugs@FDA)
- ARGENX BV Company: ARGENX SE (ARGX)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | VYVGART HYTRULO EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC | INJECTABLE;INJECTION 1008MG;11200UNITS PER 5.6ML | Prescription | – | No | Not listed |
Submissions
Orange Book patents
No Orange Book patents are listed for this application.
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Purple Book licensure
| Product | Licence | Strength and presentation | Licensed on | First licensure | Reference product | Exclusivity |
|---|---|---|---|---|---|---|
| Vyvgart Hytrulo 001efgartigimod alfa and hyaluronidase-qvfc · Argenx BV | 351(a) Licensed · Rx | 1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML) Injection · Subcutaneous · Single-Dose Vial | – | – | Orphan exclusivity expires | |
| Vyvgart Hytrulo 002efgartigimod alfa and hyaluronidase-qvfc · Argenx BV | 351(a) Licensed · Rx | 1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML) Injection · Subcutaneous · Pre-Filled Syringe | – | – | Orphan exclusivity expires |
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
VYVGART Hytrulo
EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT) · argenx US · SUBCUTANEOUS · Version 13 · effective
Indications and usage
1 INDICATIONS AND USAGE VYVGART 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) ( 1 )
Full label on DailyMed for VYVGART Hytrulo (opens in a new tab)
NDC products
2 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 73475-1221 in openFDA (opens in a new tab) | VYVGART Hytrulo efgartigimod alfa and hyaluronidase (human recombinant) | argenx US | INJECTION, SOLUTION SUBCUTANEOUS | BLA | From |
| 73475-3102 in openFDA (opens in a new tab) | VYVGART Hytrulo efgartigimod alfa and hyaluronidase (human recombinant) | argenx US | INJECTION, SOLUTION SUBCUTANEOUS | BLA | From |
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Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Purple Book (opens in a new tab)Licence: public-domain. Purple Book purplebook-2026-09.csv.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.