Source facts
FDA issued an approval letter for VYVGART, VYVGART HYTRULO on 2026-05-11. The source metadata identifies BLA 761195, BLA 761304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
VYVGART / VYVGART HYTRULO — FDA Approval Letter (BLA 761195)
Issued to ARGENX BV. Application is approved as submitted.
Issued
May 11, 2026Application
BLA • 761195
Product
VYVGART / VYVGART HYTRULO
Company
ARGENX BV
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for VYVGART / VYVGART HYTRULO?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: BLA 761195, BLA 761304.
- 3Submission: supplement.
- 4Sponsor: ARGENX BV.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the VYVGART / VYVGART HYTRULO approval letter
Is VYVGART / VYVGART HYTRULO FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761195 for VYVGART / VYVGART HYTRULO, sponsored by ARGENX BV, on May 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761195?
BLA 761195 is the application under which FDA issued this approval letter for VYVGART / VYVGART HYTRULO to ARGENX BV. The letter is dated May 11, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.