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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bispecific humanized IgG4 BCMA-directed CD3 T cell engager antibody
Date Designated: 08/20/2026
Orphan Designation: treatment of pemphigus
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ouro Medicines Ltd.
1 Ashley Road, 3rd Floor
Altrincham, Cheshire WA14 2DT
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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