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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: An antibody oligonucleotide conjugate, comprised of a human transferrin receptor 1 targeting, effector function null, humanized IgG1 antibody, a MCC maleimide linker, and a double-stranded siRNA oligonucleotide targeting DUX4
Date Designated: 02/13/2023
Orphan Designation: Treatment of facioscapulohumeral muscular dystrophy (FSHD)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Avidity Biosciences, Inc.
10578 Science Center Drive, Suite 125
San Diego, California 92121
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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