atidarsagene autotemcel
atidarsagene autotemcel is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including LENMELDY. Available dosage form: suspension.
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).