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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lunsotogene parvec-cwha
Trade Name: Otarmeni
Date Designated: 08/11/2021
Orphan Designation: Treatment of hearing loss due to mutations of the OTOF gene
Orphan Designation Status: Designated/Approved
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
United States

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

Marketing approved:

1 Generic Name: lunsotogene parvec-cwha
Trade Name: Otarmeni
Marketing Approval Date: 04/23/2026
Approved Labeled Indication: treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear
Exclusivity End Date: 04/23/2033 
Exclusivity Protected Indication* :  treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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