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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: adeno-associated virus expressing the full-length, consensus human coding sequence of gamma-sarcoglycan (SGCG)
Date Designated: 02/27/2026
Orphan Designation: treatment of limb-girdle muscular dystrophy type 2C/R5 (LGMD2C/R5)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Evolyra Therapeutics
11535 Grey Oaks Estates Run
Glen Allen, Virginia 23059
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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