← FDA DRUG APPROVALS

FDA BLA · BLA761304

VYVGART HYTRULO

efgartigimod alfa and hyaluronidase (human recombinant)

Sponsor: ARGENX BV

APPLICATION
BLA761304
TYPE
BLA
ORIGINAL APPROVAL
2023-06-20
LATEST ACTION
2026-05-08
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VYVGART HYTRULOPrescription
EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC 1008MG · INJECTABLE · INJECTION

Approval history

2026-05-08Efficacy · Supplement 18 · priority — Letter ↗AP
2026-02-26Labeling · Supplement 19 · standard — Letter ↗AP
2025-10-17Efficacy · Supplement 10 · standard — Label ↗AP
2025-04-10Efficacy · Supplement 8 · standard — Label ↗AP
2024-08-08Efficacy · Supplement 3 · standard — Letter ↗AP
2024-06-21Efficacy · Supplement 5 · priority — Label ↗AP
2024-06-21Labeling · Supplement 6 · standard — Label ↗AP
2023-12-12Labeling · Supplement 2 · standard — Letter ↗AP
2023-06-20UNKNOWN · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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