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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: efgartigimod alfa and hyaluronidase-qvfc
Trade Name: Vyvgart Hytrulo
Date Designated: 07/27/2022
Orphan Designation: Treatment of myasthenia gravis
Orphan Designation Status: Designated/Approved
argenx BV
Industriepark Zwijnaarde 7
Zwijnaarde, Ghent 9052
Belgium

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: efgartigimod alfa and hyaluronidase-qvfc
Trade Name: Vyvgart Hytrulo
Marketing Approval Date: 06/20/2023
Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive
Exclusivity End Date: 06/20/2030 
Exclusivity Protected Indication* :  treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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