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atidarsagene autotemcel

FDA Drug Profile — LENMELDY

Drug Details

Generic Name
atidarsagene autotemcel
Brand Names
LENMELDY
Application Number
BLA125758
Sponsor
Orchard Therapeutics (Europe) Ltd
NDC Codes
1
Dosage Forms
SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
ATIDARSAGENE AUTOTEMCEL

Indications and Usage

1 INDICATIONS AND USAGE LENMELDY is indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD). LENMELDY is an autologous hematopoietic stem cell-based gene therapyindicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).