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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: atidarsagene autotemcel
Trade Name: Lenmeldy
Date Designated: 03/08/2018
Orphan Designation: Treatment of the Metachromatic Leukodystrophy (including pre-symptomatic metachromatic leukodystrophy)
Orphan Designation Status: Designated/Approved
Orchard Therapeutics Ltd.
245 Hammersmith Road
London W6 8PW
United Kingdom

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

Marketing approved:

1 Generic Name: atidarsagene autotemcel
Trade Name: Lenmeldy
Marketing Approval Date: 03/18/2024
Approved Labeled Indication: treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD)
Exclusivity End Date: 03/18/2031 
Exclusivity Protected Indication* :  treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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